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A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed 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: NCT00727272
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: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Quinine Sulfate Capsules 324 mg
Drug: Quinine Sulphate Tablets 300 mg
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence ABC Treatment Sequence BCA Treatment Sequence CAB
Hide Arm/Group Description 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. 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. 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 Title: Period I
Started 9 9 9
Completed 9 9 9
Not Completed 0 0 0
Period Title: Washout Period A
Started 9 9 9
Completed 9 9 8 [1]
Not Completed 0 0 1
Reason Not Completed
Adverse Event             0             0             1
[1]
positive pregnancy test - recorded as an adverse event
Period Title: Period II
Started 9 9 8
Completed 9 9 8
Not Completed 0 0 0
Period Title: Washout Period B
Started 9 9 8
Completed 9 9 7 [1]
Not Completed 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             1
[1]
personal reasons
Period Title: Period III
Started 9 9 7
Completed 9 9 7
Not Completed 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
24.11  (8.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
15
  55.6%
Male
12
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
26
  96.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Hispanic or Latino
1
   3.7%
Not Hispanic or Latino
26
  96.3%
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 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions Treatment A, Dose Adjusted to 300 mg Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions
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 300 mg was used to evaluate for dose proportionality.
Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
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.
Overall Number of Participants Analyzed 26 26 25 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
2,246.58  (594.69) 2,080.18  (550.64) 2,278.46  (547.79) 2,539.94  (740.19)
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 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions Treatment A, Dose Adjusted to 300 mg Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions
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 300 mg was used to evaluate for dose proportionality.
Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
Each subject received one capsule of Quinine Sulfate 324 mg 30 minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
Overall Number of Participants Analyzed 26 26 25 26
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
32,689.35  (8,667.79) 30,267.96  (8,025.76) 31,689.32  (9,549.17) 34,729.00  (11,625.99)
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 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions Treatment A, Dose Adjusted to 300 mg Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions
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 300 mg was used to evaluate for dose proportionality.
Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
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.
Overall Number of Participants Analyzed 26 26 25 26
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
36,132.35  (11,054.19) 33,456.04  (10,235.39) 34,410.28  (11,636.62) 37,550.81  (14,809.14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A - Quinine Sulfate Capsules 324 mg - Fasting Treatment B - Quinine Sulphate Tablets 300 mg - Fasting Treatment C - Quinine Sulfate Capsules 324 mg - Fed
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Treatment A - Quinine Sulfate Capsules 324 mg - Fasting Treatment B - Quinine Sulphate Tablets 300 mg - Fasting Treatment C - Quinine Sulfate Capsules 324 mg - Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Treatment A - Quinine Sulfate Capsules 324 mg - Fasting Treatment B - Quinine Sulphate Tablets 300 mg - Fasting Treatment C - Quinine Sulfate Capsules 324 mg - Fed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/25 (0.00%)      0/27 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment A - Quinine Sulfate Capsules 324 mg - Fasting Treatment B - Quinine Sulphate Tablets 300 mg - Fasting Treatment C - Quinine Sulfate Capsules 324 mg - Fed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/26 (42.31%)      7/25 (28.00%)      14/27 (51.85%)    
Gastrointestinal disorders       
dyspepsia †  0/26 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1
nausea †  1/26 (3.85%)  1 2/25 (8.00%)  2 1/27 (3.70%)  1
vomiting †  0/26 (0.00%)  0 1/25 (4.00%)  1 5/27 (18.52%)  5
Infections and infestations       
viral syndrome †  0/26 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders       
musculoskeletal stiffness †  1/26 (3.85%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0
Nervous system disorders       
headache †  3/26 (11.54%)  3 3/25 (12.00%)  3 4/27 (14.81%)  4
syncope †  0/26 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0
Reproductive system and breast disorders       
unintended pregnancy †  0/26 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders       
nasal congestion †  1/26 (3.85%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0
pharyngolaryngeal pain †  3/26 (11.54%)  3 0/25 (0.00%)  0 1/27 (3.70%)  1
sinus pain †  1/26 (3.85%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0
upper respiratory infection †  1/26 (3.85%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0
†
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 Davis, MD, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00727272    
Other Study ID Numbers: RA3-085
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