Trial Outcomes & Findings for A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg (NCT NCT00726414)
NCT ID: NCT00726414
Last Updated: 2010-02-03
Results Overview
The maximum or peak concentration that Quinine Sulfate reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) 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 drug administration.
Results posted on
2010-02-03
Participant Flow
Participant milestones
| Measure |
Quinine Sulfate Under Fasted Then Fed Conditions
On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast.
|
Quinine Sulfate Under Fed Then Fasted Conditions
On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
|
First Intervention
COMPLETED
|
11
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
11
|
11
|
|
Washout Period of 7 Days
COMPLETED
|
11
|
11
|
|
Washout Period of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
11
|
11
|
|
Second Intervention
COMPLETED
|
11
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg
Baseline characteristics by cohort
| Measure |
Quinine Sulfate Under Fed and Fasted Conditions
n=22 Participants
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast or 30 minutes following a standardized, high fat breakfast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
20.6 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) 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 drug administration.Population: Data from all 22 subjects enrolled in this study were used in the statistical analysis.
The maximum or peak concentration that Quinine Sulfate reaches in the plasma.
Outcome measures
| Measure |
Quinine Sulfate Under Fasted Conditions
n=22 Participants
Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
|
Quinine Sulfate Under Fed Conditions
n=22 Participants
Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Quinine Sulfate
|
3,293.84 ng/mL
Standard Deviation 750.85
|
3,424.30 ng/mL
Standard Deviation 859.91
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) 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 drug administration.Population: Data from all 22 subjects enrolled in this study were used in the statistical analysis.
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 |
Quinine Sulfate Under Fasted Conditions
n=22 Participants
Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
|
Quinine Sulfate Under Fed Conditions
n=22 Participants
Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate
|
49,484.64 ng-hr/mL
Standard Deviation 15,831.86
|
51,228.07 ng-hr/mL
Standard Deviation 16,690.68
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) 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 drug administration.Population: Data from all 22 subjects enrolled in this study were used in the statistical analysis.
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 |
Quinine Sulfate Under Fasted Conditions
n=22 Participants
Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
|
Quinine Sulfate Under Fed Conditions
n=22 Participants
Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate
|
52,643.14 ng-hr/mL
Standard Deviation 18,056.00
|
54,409.12 ng-hr/mL
Standard Deviation 18,706.05
|
Adverse Events
Quinine Sulfate Under Fasted Conditions
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Quinine Sulfate Under Fed Conditions
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quinine Sulfate Under Fasted Conditions
n=22 participants at risk
Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
|
Quinine Sulfate Under Fed Conditions
n=22 participants at risk
Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
Tremor
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.5%
1/22 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Endocrine disorders
Dysmenorrhea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60