Trial Outcomes & Findings for A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions (NCT NCT00727272)
NCT ID: NCT00727272
Last Updated: 2010-01-20
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.
Results posted on
2010-01-20
Participant Flow
Participant milestones
| Measure |
Treatment Sequence ABC
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
Treatment Sequence BCA
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
Treatment Sequence CAB
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
|---|---|---|---|
|
Period I
STARTED
|
9
|
9
|
9
|
|
Period I
COMPLETED
|
9
|
9
|
9
|
|
Period I
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period A
STARTED
|
9
|
9
|
9
|
|
Washout Period A
COMPLETED
|
9
|
9
|
8
|
|
Washout Period A
NOT COMPLETED
|
0
|
0
|
1
|
|
Period II
STARTED
|
9
|
9
|
8
|
|
Period II
COMPLETED
|
9
|
9
|
8
|
|
Period II
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period B
STARTED
|
9
|
9
|
8
|
|
Washout Period B
COMPLETED
|
9
|
9
|
7
|
|
Washout Period B
NOT COMPLETED
|
0
|
0
|
1
|
|
Period III
STARTED
|
9
|
9
|
7
|
|
Period III
COMPLETED
|
9
|
9
|
7
|
|
Period III
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence ABC
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
Treatment Sequence BCA
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
Treatment Sequence CAB
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
|---|---|---|---|
|
Washout Period A
Adverse Event
|
0
|
0
|
1
|
|
Washout Period B
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=27 Participants
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under Fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.11 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.Population: Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions
n=26 Participants
Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
|
Treatment A, Dose Adjusted to 300 mg
n=26 Participants
This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
|
Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions
n=25 Participants
Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
|
Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions
n=26 Participants
Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2,246.58 ng/mL
Standard Deviation 594.69
|
2,080.18 ng/mL
Standard Deviation 550.64
|
2,278.46 ng/mL
Standard Deviation 547.79
|
2,539.94 ng/mL
Standard Deviation 740.19
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.Population: Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions
n=26 Participants
Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
|
Treatment A, Dose Adjusted to 300 mg
n=26 Participants
This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
|
Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions
n=25 Participants
Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
|
Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions
n=26 Participants
Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
|
|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
32,689.35 ng-hr/mL
Standard Deviation 8,667.79
|
30,267.96 ng-hr/mL
Standard Deviation 8,025.76
|
31,689.32 ng-hr/mL
Standard Deviation 9,549.17
|
34,729.00 ng-hr/mL
Standard Deviation 11,625.99
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.Population: Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions
n=26 Participants
Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
|
Treatment A, Dose Adjusted to 300 mg
n=26 Participants
This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
|
Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions
n=25 Participants
Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
|
Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions
n=26 Participants
Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
|
|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
36,132.35 ng-hr/mL
Standard Deviation 11,054.19
|
33,456.04 ng-hr/mL
Standard Deviation 10,235.39
|
34,410.28 ng-hr/mL
Standard Deviation 11,636.62
|
37,550.81 ng-hr/mL
Standard Deviation 14,809.14
|
Adverse Events
Treatment A - Quinine Sulfate Capsules 324 mg - Fasting
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment B - Quinine Sulphate Tablets 300 mg - Fasting
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment C - Quinine Sulfate Capsules 324 mg - Fed
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A - Quinine Sulfate Capsules 324 mg - Fasting
n=26 participants at risk
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
Treatment B - Quinine Sulphate Tablets 300 mg - Fasting
n=25 participants at risk
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
Treatment C - Quinine Sulfate Capsules 324 mg - Fed
n=27 participants at risk
All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/26
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
headache
|
11.5%
3/26 • Number of events 3
|
12.0%
3/25 • Number of events 3
|
14.8%
4/27 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
|
Gastrointestinal disorders
nausea
|
3.8%
1/26 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
11.5%
3/26 • Number of events 3
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
|
Reproductive system and breast disorders
unintended pregnancy
|
0.00%
0/26
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
|
Infections and infestations
viral syndrome
|
0.00%
0/26
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
18.5%
5/27 • Number of events 5
|
|
Nervous system disorders
syncope
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60