Trial Outcomes & Findings for A Phase I Study to Assess PK of AZD7986 Alone & With Verapamil, Itraconazole or Diltiazem in Healthy Subjects (NCT NCT02653872)
NCT ID: NCT02653872
Last Updated: 2018-02-23
Results Overview
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose
Results posted on
2018-02-23
Participant Flow
This study was conducted at PAREXEL Early Phase Clinical Unit - London
Fifteen healthy male subjects were enrolled in the study to assess the pharmacokinetics (PK) of AZD7986 when administered alone (Treatment Period 1) and in combination with multiple doses of verapamil (Treatment Period 2) and itraconazole (Treatment Period 3).
Participant milestones
| Measure |
All Participants
All 15 participants who were enrolled in the study and who received at least a single dose of the study drug in three treatment periods in a fixed sequence and were separated by a washout period.
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|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
Treatment Period 1:
|
15
|
|
Overall Study
Treatment Period 2:
|
15
|
|
Overall Study
Treatment Period 3:
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I Study to Assess PK of AZD7986 Alone & With Verapamil, Itraconazole or Diltiazem in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
All 15 participants who were enrolled in the study and who received at least a single dose of the study drug in three treatment periods in a fixed sequence and were separated by a washout period.
|
|---|---|
|
Age, Continuous
|
33 Years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
|
|---|---|---|---|
|
Effect of Verapamil and the Effect of Itraconazole on the PK of AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax).
|
385.8 nmol/L
Geometric Coefficient of Variation 27.4
|
591.9 nmol/L
Geometric Coefficient of Variation 27.1
|
234.1 nmol/L
Geometric Coefficient of Variation 39.0
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the effect of verapamil and itraconazole on the PK of AZD7986.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
|
|---|---|---|---|
|
Effect of Verapamil and the Effect of Itraconazole on the PK of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC).
|
6697 h*nmol/L
Geometric Coefficient of Variation 44.8
|
8857 h*nmol/L
Geometric Coefficient of Variation 43.3
|
7615 h*nmol/L
Geometric Coefficient of Variation 35.1
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
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|---|---|---|---|
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Pharmacokinetics (PK) of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-t]).
|
6545 h*nmol/L
Geometric Coefficient of Variation 44.8
|
8739 h*nmol/L
Geometric Coefficient of Variation 43.5
|
7361 h*nmol/L
Geometric Coefficient of Variation 34.4
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
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|---|---|---|---|
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Pharmacokinetics (PK) of AZD7986 by Assessment of Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz).
|
23.35 hours
Standard Deviation 5.731
|
20.36 hours
Standard Deviation 4.812
|
27.89 hours
Standard Deviation 5.407
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
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|---|---|---|---|
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Pharmacokinetics (PK) of AZD7986 by Assessment of the Time to Reach Maximum Plasma Concentration (Tmax)
|
0.75 hours
Interval 0.48 to 3.0
|
1.50 hours
Interval 0.73 to 1.52
|
1.50 hours
Interval 0.75 to 2.0
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
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|---|---|---|---|
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Pharmacokinetics (PK) of AZD7986 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F).
|
9.807 L/h
Standard Deviation 5.267
|
7.359 L/h
Standard Deviation 3.765
|
8.308 L/h
Standard Deviation 3.452
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
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|---|---|---|---|
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Pharmacokinetics (PK) of AZD7986 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F).
|
297.1 Litres
Standard Deviation 83.48
|
194.6 Litres
Standard Deviation 41.68
|
317.8 Litres
Standard Deviation 89.06
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the area under the plasma concentration-time curve from time over the dosing interval tau (24 hours) of Verapamil, itraconazole and OH-itraconazole (a metabolite of Itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
|
|---|---|---|---|
|
Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC [0 - τ]) of Verapamil, Itraconazole and OH-itraconazole Following Co-administration of AZD7986 With Verapamil or Itraconazole.
|
2178 h*nmol/L
Geometric Coefficient of Variation 44.7
|
18090 h*nmol/L
Geometric Coefficient of Variation 22.6
|
31390 h*nmol/L
Geometric Coefficient of Variation 19.8
|
PRIMARY outcome
Timeframe: Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To assess the time to reach maximum observed concentration of Verapamil, Itraconazole and OH-itraconazole (a metabolite of itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.
Outcome measures
| Measure |
AZD7986
n=15 Participants
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 Participants
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 Participants
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
|
|---|---|---|---|
|
Assessment of the Tmax of Verapamil, Itraconazole and OH-itraconazole Following Co-administration of AZD7986 With Verapamil or Itraconazole.
|
4.00 hours
Interval 1.48 to 12.02
|
1.50 hours
Interval 0.73 to 2.0
|
5.00 hours
Interval 1.0 to 23.93
|
Adverse Events
AZD7986
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD7986 + Verapamil
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AZD7986 + Itraconazole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Verapamil
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Itraconazole
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
All Subjects
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD7986
n=15 participants at risk
Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
|
AZD7986 + Verapamil
n=15 participants at risk
Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
|
AZD7986 + Itraconazole
n=15 participants at risk
Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
|
Verapamil
n=15 participants at risk
Participants received Verapamil
|
Itraconazole
n=15 participants at risk
Participants received Itraconazole.
|
All Subjects
n=15 participants at risk
Overall number of participants in the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
20.0%
3/15 • Number of events 3 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
20.0%
3/15 • Number of events 3 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
20.0%
3/15 • Number of events 3 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
20.0%
3/15 • Number of events 3 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Gastrointestinal disorders
Gingival bleeding
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
13.3%
2/15 • Number of events 2 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
20.0%
3/15 • Number of events 3 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
20.0%
3/15 • Number of events 3 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
33.3%
5/15 • Number of events 5 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
46.7%
7/15 • Number of events 7 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
13.3%
2/15 • Number of events 2 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
13.3%
2/15 • Number of events 2 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
13.3%
2/15 • Number of events 2 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
26.7%
4/15 • Number of events 4 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Infections and infestations
Oral herpes
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
2/15 • Number of events 2 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
20.0%
3/15 • Number of events 3 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
46.7%
7/15 • Number of events 7 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
13.3%
2/15 • Number of events 2 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
13.3%
2/15 • Number of events 2 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
General disorders
Injection site pain
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
0.00%
0/15 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
6.7%
1/15 • Number of events 1 • Treatment Period 1: Day -1 up to 96 hours post-dose; Treatment Period 2: Day -1 up to morning of Day 9,; Treatment Period 3: Day -1 up to Day 10 (itraconazole).
An AE is an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs which met the "Definitions of Serious Adverse Event" defined in the clinical study protocol were regarded as SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All of the study information and data collected during the study were considered confidential and the property of AstraZeneca. After completion of the study, the investigator should prepare a joint publication with AstraZeneca. The investigator must undertake not to submit any part of the individual data from this clinical study protocol for publication without prior consent of AstraZeneca at a mutually agreed time.
- Publication restrictions are in place
Restriction type: OTHER