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Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

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ClinicalTrials.gov Identifier: NCT00806078
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : July 8, 2009
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Intervention Drug: quinine sulfate
Enrollment 18
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Quinine Alone First Quinine With Chocolate Pudding First
Hide Arm/Group Description 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. 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.
Period Title: First Intervention
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: 7 Day Washout Period
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Second Intervention
Started 9 9
Completed 9 9
Not Completed 0 0
Arm/Group Title Quinine Alone First Quinine With Chocolate Pudding First Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
35.5  (8.4) 35.5  (8.4) 35.5  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
3
  33.3%
3
  33.3%
6
  33.3%
Male
6
  66.7%
6
  66.7%
12
  66.7%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed per protocol
Arm/Group Title Quinine Alone Quinine With Chocolate Pudding
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ng per mL
3291.411  (658.529) 3439.867  (646.818)
2.Primary Outcome
Title Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed per protocol
Arm/Group Title Quinine Alone Quinine With Chocolate Pudding
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ng·h/mL
555973.3  (15455.81) 56008.6  (12979.18)
3.Primary Outcome
Title The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)
Hide Description 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
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed per protocol
Arm/Group Title Quinine Alone Quinine With Chocolate Pudding
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ng-h/ml
61887.4  (18880.15) 60764.9  (14998.61)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quinine Alone First Quinine With Chocolate Pudding First
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Quinine Alone First Quinine With Chocolate Pudding First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Quinine Alone First Quinine With Chocolate Pudding First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Quinine Alone First Quinine With Chocolate Pudding First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/18 (38.89%)      10/18 (55.56%)    
Gastrointestinal disorders     
Nausea * 1  0/18 (0.00%)  0 2/18 (11.11%)  2
General disorders     
Feeling hot * 1  3/18 (16.67%)  5 2/18 (11.11%)  2
Nervous system disorders     
Dizziness * 2  2/18 (11.11%)  2 5/18 (27.78%)  5
Headache * 1  2/18 (11.11%)  2 1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MeDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Director
Organization: Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
EMail: clinicaltrials@urlmutual.com
Layout table for additonal information
Responsible Party: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00806078    
Other Study ID Numbers: MPC-001-07-1004
First Submitted: December 8, 2008
First Posted: December 10, 2008
Results First Submitted: December 18, 2008
Results First Posted: July 8, 2009
Last Update Posted: August 31, 2012