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Sponsored by: |
Mutual Pharmaceutical Company, Inc. |
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Information provided by: | Mutual Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00685165 |
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline(primidone tablets) in adult subjects under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Therapeutic Equivalency |
Drug: primidone |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet of Primidone 50mg, Compared to an Equivalent Dose of Mysoline in Healthy Adult Subjects |
Enrollment: | 22 |
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: Experimental
One tablet containing 50mg of test product to be administered at hour 0 on Day 1 of each test period
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Drug: primidone
50 mg tablet
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B: Active Comparator
One Mysoline tablet containing 50mg reference product to be administered at hour 0 on Day 1 of each test period
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Drug: primidone
50 mg tablet
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mutual Pharmaceutical Company, Inc. ( Kristin Arnold, Vice President R&D ) |
Study ID Numbers: | 04090 |
Study First Received: | May 24, 2008 |
Last Updated: | May 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00685165 History of Changes |
Health Authority: | United States: Institutional Review Board |
Primidone Healthy Anticonvulsants |
Primidone Therapeutic Uses Central Nervous System Agents Pharmacologic Actions Anticonvulsants |