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A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00726895
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : December 30, 2009
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition Healthy
Intervention Drug: Quinine Sulfate Capsules 324 mg
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quinine Sulfate Capsules 1 x 324 mg Dose Then 2 x 324 mg Dose Quinine Sulfate Capsules 2 x 324 mg Dose Then 1 x 324 mg Dose
Hide Arm/Group Description All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days. All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout Period of 7 Days
Started 12 12
Completed 12 11
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Second Intervention
Started 12 11
Completed 12 11
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description 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 either one Quinine Sulfate 324 mg capsule or two Quinine Sulfate 324 mg capsules following an overnight fast of at least 10 hours.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
33  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
11
  45.8%
Male
13
  54.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
1
   4.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
23
  95.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description The maximum or peak concentration that the drug reaches in the plasma.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.
Arm/Group Title Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose) Treatment A, Dose Adjusted to 2 x 324 mg Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)
Hide Arm/Group Description:
Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
2,118.35  (517.79) 4,236.70  (1,035.58) 3,242.92  (685.80)
2.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.
Arm/Group Title Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose) Treatment A, Dose Adjusted to 2 x 324 mg Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)
Hide Arm/Group Description:
Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23 23
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
31,951.03  (10,428.59) 63,902.06  (20,857.17) 56,198.20  (15,683.25)
3.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.
Arm/Group Title Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose) Treatment A, Dose Adjusted to 2 x 324 mg Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)
Hide Arm/Group Description:
Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23 23
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
35,199.28  (12,678.60) 70,398.56  (25,357.19) 61,570.10  (19,295.34)
Time Frame [Not Specified]
Adverse Event Reporting Description 24 subjects were enrolled in this study. One subject dropped out of the study prior to receiving both interventions. 23 subjects were administered the Quinine Sulfate 1 x 324 mg capsule dose and 24 subjects were admistered the Quinine Sulfate 2 x 324 mg capusle dose.
 
Arm/Group Title Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose
Hide Arm/Group Description All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days. All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
All-Cause Mortality
Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/24 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/23 (26.09%)      10/24 (41.67%)    
Gastrointestinal disorders     
Diarrhea †  0/23 (0.00%)  0 1/24 (4.17%)  1
Nausea †  0/23 (0.00%)  0 3/24 (12.50%)  3
Stomach discomfort †  0/23 (0.00%)  0 1/24 (4.17%)  1
General disorders     
Generalized pain †  0/23 (0.00%)  0 1/24 (4.17%)  1
Pain in extremity †  0/23 (0.00%)  0 1/24 (4.17%)  1
Pallor †  1/23 (4.35%)  1 1/24 (4.17%)  1
Rigors †  0/23 (0.00%)  0 1/24 (4.17%)  1
Injury, poisoning and procedural complications     
Skin laceration †  0/23 (0.00%)  0 1/24 (4.17%)  1
Metabolism and nutrition disorders     
Loss of appetite †  0/23 (0.00%)  0 1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders     
Joint injury †  1/23 (4.35%)  1 0/24 (0.00%)  0
Myalgia in extremities †  1/23 (4.35%)  1 0/24 (0.00%)  0
Nervous system disorders     
Dizziness †  0/23 (0.00%)  0 3/24 (12.50%)  3
Headache †  2/23 (8.70%)  2 2/24 (8.33%)  2
Syncope †  2/23 (8.70%)  2 0/24 (0.00%)  0
Tinnitus †  0/23 (0.00%)  0 1/24 (4.17%)  1
Reproductive system and breast disorders     
Dysmenorrhea †  0/23 (0.00%)  0 1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal - Sore throat †  0/23 (0.00%)  0 1/24 (4.17%)  1
Tonsillitis †  0/23 (0.00%)  0 1/24 (4.17%)  1
Upper respiratory tract infection †  1/23 (4.35%)  1 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders     
Night Sweats †  1/23 (4.35%)  1 0/24 (0.00%)  0
Sweating increased †  0/23 (0.00%)  0 1/24 (4.17%)  1
†
Indicates events were collected by systematic assessment
[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 Director
Organization: Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
EMail: clinicaltrials@urlmutual.com
Layout table for additonal information
Responsible Party: Matthew W. Davis, MD,, Mutual Pharmaceutical
ClinicalTrials.gov Identifier: NCT00726895    
Other Study ID Numbers: R04-0376
First Submitted: July 30, 2008
First Posted: August 1, 2008
Results First Submitted: November 24, 2009
Results First Posted: December 30, 2009
Last Update Posted: January 20, 2010