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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Cetero Research |
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Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00652639 |
To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg
Condition | Intervention | Phase |
---|---|---|
To Determine Bioequivalence Under Fasting Conditions |
Drug: Clonazepam Drug: Klonopin |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Comparative, Randomized, Single-Dose, 2 Way Cross Over Bioavailability Study of Kali's Clonazepam Tablets 1 mg With That of Klonopin Tablets 1 mg in Healthy Adult Subjects Under Fasting Conditions. |
Enrollment: | 32 |
Study Start Date: | February 2004 |
Study Completion Date: | April 2004 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Subjects received the kali formulated products under fasting conditions
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Drug: Clonazepam
Tablets, 1 mg, single-dose
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B: Active Comparator
Subjects received the Roche formulated products under fasting conditions
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Drug: Klonopin
tablets, 1 mg, single-dose
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To compare the single -dose bioavailability of kali's Clonazepam tablets 1 mg with that of Klonopin tablets 1 mg by Roche pharmaceuticals following a single oral dose under fasting conditions.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Par Pharmaceutical, Inc. ( Dr. Alfred Elvin/ Director Biopharmaceutics ) |
Study ID Numbers: | B043201 |
Study First Received: | April 1, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00652639 |
Health Authority: | United States: Food and Drug Administration |
bioequivalence, Clonazepam tablets, fasting |
Clonazepam Healthy |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Therapeutic Uses Physiological Effects of Drugs |
GABA Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |