Trial Outcomes & Findings for Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions (NCT NCT01764945)
NCT ID: NCT01764945
Last Updated: 2015-07-31
Results Overview
Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.
Results posted on
2015-07-31
Participant Flow
Participant milestones
| Measure |
40mg Faldaprevir: Sequence Group ADBC
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group BACD
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group CBDA
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group DCAB
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group EHFG
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group FEGH
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group GFHE
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group HGEF
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
10
|
8
|
9
|
9
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
5
|
10
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
40mg Faldaprevir: Sequence Group ADBC
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group BACD
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group CBDA
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group DCAB
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group EHFG
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group FEGH
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group GFHE
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group HGEF
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions
Baseline characteristics by cohort
| Measure |
40mg Faldaprevir: Sequence Group ADBC
n=5 Participants
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group BACD
n=5 Participants
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group CBDA
n=5 Participants
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
40mg Faldaprevir: Sequence Group DCAB
n=5 Participants
40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group EHFG
n=10 Participants
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group FEGH
n=8 Participants
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group GFHE
n=9 Participants
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
120mg Faldaprevir: Sequence Group HGEF
n=9 Participants
120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast).
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
38.0 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
33.9 years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
38.6 years
STANDARD_DEVIATION 9.6 • n=8 Participants
|
39.4 years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
34.9 years
STANDARD_DEVIATION 9.5 • n=24 Participants
|
38.1 years
STANDARD_DEVIATION 8.5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.Population: Pharmacokinetic analysis set (PK set) includes all subjects who provided evaluable data for at least 1 evaluable observation for a PK endpoint in at least 1 treatment period.
Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
40mg Faldaprevir: Treatment A
n=19 Participants
40 mg faldaprevir soft gelatine capsule (reference).
|
40mg Faldaprevir: Treatment B
n=19 Participants
40 mg faldaprevir oral solution 1
|
40mg Faldaprevir: Treatment C
n=20 Participants
40 mg faldaprevir oral solution 2
|
40mg Faldaprevir: Treatment D
n=18 Participants
40 mg faldaprevir oral solution 3
|
120mg Faldaprevir: Treatment E
n=35 Participants
120 mg faldaprevir soft gelatine capsule (reference).
|
120mg Faldaprevir: Treatment F
n=35 Participants
120 mg faldaprevir oral solution 1
|
120mg Faldaprevir: Treatment G
n=36 Participants
120 mg faldaprevir oral solution 2
|
120mg Faldaprevir: Treatment H
n=35 Participants
120 mg faldaprevir oral solution 3
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-∞
|
3960 ng*h/mL
Geometric Coefficient of Variation 32.3
|
3400 ng*h/mL
Geometric Coefficient of Variation 28.5
|
3350 ng*h/mL
Geometric Coefficient of Variation 28.4
|
3420 ng*h/mL
Geometric Coefficient of Variation 30.4
|
15000 ng*h/mL
Geometric Coefficient of Variation 34.5
|
13900 ng*h/mL
Geometric Coefficient of Variation 38.8
|
14500 ng*h/mL
Geometric Coefficient of Variation 38.3
|
14100 ng*h/mL
Geometric Coefficient of Variation 36.0
|
PRIMARY outcome
Timeframe: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.Population: PK set.
Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
40mg Faldaprevir: Treatment A
n=19 Participants
40 mg faldaprevir soft gelatine capsule (reference).
|
40mg Faldaprevir: Treatment B
n=19 Participants
40 mg faldaprevir oral solution 1
|
40mg Faldaprevir: Treatment C
n=20 Participants
40 mg faldaprevir oral solution 2
|
40mg Faldaprevir: Treatment D
n=18 Participants
40 mg faldaprevir oral solution 3
|
120mg Faldaprevir: Treatment E
n=35 Participants
120 mg faldaprevir soft gelatine capsule (reference).
|
120mg Faldaprevir: Treatment F
n=35 Participants
120 mg faldaprevir oral solution 1
|
120mg Faldaprevir: Treatment G
n=36 Participants
120 mg faldaprevir oral solution 2
|
120mg Faldaprevir: Treatment H
n=35 Participants
120 mg faldaprevir oral solution 3
|
|---|---|---|---|---|---|---|---|---|
|
Cmax
|
86.4 ng/mL
Geometric Coefficient of Variation 36.0
|
65.4 ng/mL
Geometric Coefficient of Variation 39.0
|
64.0 ng/mL
Geometric Coefficient of Variation 40.4
|
69.7 ng/mL
Geometric Coefficient of Variation 28.1
|
625.0 ng/mL
Geometric Coefficient of Variation 47.3
|
481.0 ng/mL
Geometric Coefficient of Variation 47.1
|
488.0 ng/mL
Geometric Coefficient of Variation 52.1
|
485.0 ng/mL
Geometric Coefficient of Variation 48.4
|
PRIMARY outcome
Timeframe: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.Population: PK set.
Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 to the time of the last quantifiable data point. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
40mg Faldaprevir: Treatment A
n=19 Participants
40 mg faldaprevir soft gelatine capsule (reference).
|
40mg Faldaprevir: Treatment B
n=19 Participants
40 mg faldaprevir oral solution 1
|
40mg Faldaprevir: Treatment C
n=20 Participants
40 mg faldaprevir oral solution 2
|
40mg Faldaprevir: Treatment D
n=18 Participants
40 mg faldaprevir oral solution 3
|
120mg Faldaprevir: Treatment E
n=35 Participants
120 mg faldaprevir soft gelatine capsule (reference).
|
120mg Faldaprevir: Treatment F
n=35 Participants
120 mg faldaprevir oral solution 1
|
120mg Faldaprevir: Treatment G
n=36 Participants
120 mg faldaprevir oral solution 2
|
120mg Faldaprevir: Treatment H
n=35 Participants
120 mg faldaprevir oral solution 3
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-tz
|
3020 ng*h/mL
Geometric Coefficient of Variation 29.4
|
2600 ng*h/mL
Geometric Coefficient of Variation 32.9
|
2520 ng*h/mL
Geometric Coefficient of Variation 38.3
|
2550 ng*h/mL
Geometric Coefficient of Variation 34.3
|
14200 ng*h/mL
Geometric Coefficient of Variation 35.2
|
12900 ng*h/mL
Geometric Coefficient of Variation 39.4
|
13400 ng*h/mL
Geometric Coefficient of Variation 38.0
|
13100 ng*h/mL
Geometric Coefficient of Variation 37.0
|
Adverse Events
40mg Faldaprevir: Treatment A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
40mg Faldaprevir: Treatment B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
40mg Faldaprevir: Treatment C
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
40mg Faldaprevir: Treatment D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
120mg Faldaprevir: Treatment E
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
120mg Faldaprevir: Treatment F
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
120mg Faldaprevir: Treatment G
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
120mg Faldaprevir: Treatment H
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
40mg Faldaprevir: Treatment A
n=19 participants at risk
40 mg faldaprevir soft gelatine capsule (reference).
|
40mg Faldaprevir: Treatment B
n=20 participants at risk
40 mg faldaprevir oral solution 1.
|
40mg Faldaprevir: Treatment C
n=20 participants at risk
40 mg faldaprevir oral solution 2.
|
40mg Faldaprevir: Treatment D
n=19 participants at risk
40 mg faldaprevir oral solution 3.
|
120mg Faldaprevir: Treatment E
n=35 participants at risk
120 mg faldaprevir soft gelatine capsule (reference).
|
120mg Faldaprevir: Treatment F
n=36 participants at risk
120 mg faldaprevir oral solution 1.
|
120mg Faldaprevir: Treatment G
n=36 participants at risk
120 mg faldaprevir oral solution 2.
|
120mg Faldaprevir: Treatment H
n=35 participants at risk
120 mg faldaprevir oral solution 3.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Oral herpes
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
10.0%
2/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.6%
2/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.0%
1/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.8%
1/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.0%
1/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.0%
1/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
8.3%
3/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.0%
1/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.0%
1/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
11.4%
4/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.8%
1/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
20.0%
4/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
8.3%
3/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
11.1%
4/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
11.4%
4/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.0%
1/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
10.5%
2/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.0%
1/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
10.5%
2/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.8%
1/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.8%
1/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.9%
1/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
2.8%
1/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/20 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
5.3%
1/19 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/36 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
0.00%
0/35 • AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER