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Sponsored by: |
Mutual Pharmaceutical Company, Inc. |
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Information provided by: | Mutual Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00726414 |
A randomized, single-dose, two-way crossover study under fed and fasted conditions in 22 healthy male and female subjects
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: quinine sulfate |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-availability Study |
Official Title: | A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg Under Fasting and Fed Conditions |
Enrollment: | 22 |
Study Start Date: | December 2005 |
Study Completion Date: | December 2005 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Two 324mg capsules with 240mL of room temperature water after an overnight fast
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Drug: quinine sulfate
two 324mg capsules with water after an overnight fast
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B: Active Comparator
Two 324mg capsules with 240mL of room temperature water 30 minutes after initiation of a standardized, high fat breakfast
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Drug: quinine sulfate
two 324mg capsules 30 minutes after breakfast
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mutual Pharmaceutical Company, Inc. ( Matthew Davis, M.D. ) |
Study ID Numbers: | R05-1613 |
Study First Received: | July 30, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00726414 |
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 |