Trial Outcomes & Findings for Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding (NCT NCT00806078)
NCT ID: NCT00806078
Last Updated: 2012-08-31
Results Overview
The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours
Results posted on
2012-08-31
Participant Flow
Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) either as intact capsules or capsules opened and their contents mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Following a 7 day wash out period, all participants were given the alternate dose under similar conditions.
Participant milestones
| Measure |
Quinine Alone First
Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) as intact capsules after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize quinine pharmacokinetics after this dose. Following a 7 day wash out period, all participants were given quinine 648 mg (2 x 324 mg) as capsules opened and their contents mixed in 120 mL chocolate pudding under similar conditions.
|
Quinine With Chocolate Pudding First
Participants were randomized to receive a single dose of Quinine 648 mg (2 x 324 mg capsules) opened and mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. Following a 7 day wash out period, all participants were given Quinine 648 mg (2 x 324 mg) as intact capsules under similar conditions.
|
|---|---|---|
|
First Intervention
STARTED
|
9
|
9
|
|
First Intervention
COMPLETED
|
9
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
7 Day Washout Period
STARTED
|
9
|
9
|
|
7 Day Washout Period
COMPLETED
|
9
|
9
|
|
7 Day Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
9
|
9
|
|
Second Intervention
COMPLETED
|
9
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
Baseline characteristics by cohort
| Measure |
Quinine Alone First
n=9 Participants
After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
|
Quinine With Chocolate Pudding First
n=9 Participants
After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
35.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
35.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hoursPopulation: Analysis was performed per protocol
The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods
Outcome measures
| Measure |
Quinine Alone
n=18 Participants
After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
|
Quinine With Chocolate Pudding
n=18 Participants
After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
3291.411 ng per mL
Standard Deviation 658.529
|
3439.867 ng per mL
Standard Deviation 646.818
|
PRIMARY outcome
Timeframe: After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hoursPopulation: Analysis was performed per protocol
The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent.
Outcome measures
| Measure |
Quinine Alone
n=18 Participants
After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
|
Quinine With Chocolate Pudding
n=18 Participants
After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
|
|---|---|---|
|
Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)
|
555973.3 ng·h/mL
Standard Deviation 15455.81
|
56008.6 ng·h/mL
Standard Deviation 12979.18
|
PRIMARY outcome
Timeframe: After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hoursPopulation: Analysis was performed per protocol
AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods
Outcome measures
| Measure |
Quinine Alone
n=18 Participants
After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
|
Quinine With Chocolate Pudding
n=18 Participants
After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
|
|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)
|
61887.4 ng-h/ml
Standard Deviation 18880.15
|
60764.9 ng-h/ml
Standard Deviation 14998.61
|
Adverse Events
Quinine Alone First
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Quinine With Chocolate Pudding First
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quinine Alone First
n=18 participants at risk
After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
|
Quinine With Chocolate Pudding First
n=18 participants at risk
After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
|
|---|---|---|
|
General disorders
Feeling hot
|
16.7%
3/18 • Number of events 5
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2
|
27.8%
5/18 • Number of events 5
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
|
11.1%
2/18 • Number of events 2
|
Additional Information
Medical Affairs Director
Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60