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Sponsored by: |
Mutual Pharmaceutical Company, Inc. |
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Information provided by: | Mutual Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00726895 |
This study will compare the dose proportionality of 324mg Quinine Sulfate Capsules following a single oral dose (1 x 324mg capsule vs. 2 x 324mg capsules) in healthy adult volunteers when administered under fasting conditions
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: quinine sulfate |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Subject), Single Group Assignment, Bio-availability Study |
Official Title: | A Randomized, Two-Way Crossover Design Used to Compare the Dose Proportionality of Quinine Sulfate Capsules USP, 324mg Following a Single Oral Dose of 1 x 324mg Capsule Versus 2 x 324mg Capsules in Healthy Adult Volunteers |
Enrollment: | 24 |
Study Start Date: | May 2004 |
Study Completion Date: | June 2004 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
One 324mg capsule administered under fasting conditions
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Drug: quinine sulfate
1 x 324mg capsule
|
B: Active Comparator
Two 324mg capsules administered under fasting conditions
|
Drug: quinine sulfate
2 x 324mg capsules
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
If female and:
Exclusion Criteria:
Responsible Party: | Mutual Pharmaceutical ( Matthew W. Davis, MD, ) |
Study ID Numbers: | R04-0376 |
Study First Received: | July 30, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00726895 |
Health Authority: | United States: Food and Drug Administration |
Bioavailability |
Quinine Healthy |
Anti-Infective Agents Antiprotozoal Agents Physiological Effects of Drugs Neuromuscular Agents Pharmacologic Actions Antimalarials Antiparasitic Agents |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Muscle Relaxants, Central Peripheral Nervous System Agents Analgesics Central Nervous System Agents |