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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: | NCT00652912 |
To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg ODT
Condition | Intervention | Phase |
---|---|---|
To Determine Bioequivalence Under Fasting Conditions |
Drug: Clonazepam Drug: Klonopin Wafers |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment |
Official Title: | Comparative, Randomized, Single-Dose, Bioavailability Study of Kali's Clonazepam ODT 1 mg With That of Klonopin Wafers 1 mg ODT in Healthy Adult Subjects Under Fasting Conditions. |
Enrollment: | 32 |
Study Start Date: | March 2004 |
Study Completion Date: | May 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Subjects received the Kali formulated products under fasting conditions
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Drug: Clonazepam
ODT, 1 mg
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B: Active Comparator
Subjects received the Roche's product under fasting conditions
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Drug: Klonopin Wafers
ODT, 1 mg
|
To compare the single -dose bioavailability of kali's Clonazepam ODT 1 mg with that of Klonopin Wafers 1 mg ODT 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: | B043204 |
Study First Received: | April 1, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00652912 |
Health Authority: | United States: Food and Drug Administration |
bioequivalence, Clonazepam ODT , 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 |