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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Algorithme Pharma Inc |
Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00654277 |
To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT
Condition | Intervention | Phase |
Healthy |
Drug: Ondansetron Drug: Zofran |
Phase I |
ChemIDplus related topics: | Ondansetron Ondansetron hydrochloride |
Study Type: | Interventional |
Study Design: | Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 8 mg ODT With That of GlaxoSmithKine's Zofran 8 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions |
Enrollment: | 32 |
Study Start Date: | August 2002 |
Study Completion Date: | September 2002 |
Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Subjects received Kali formulated products under fasting conditions
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Drug: Ondansetron
ODT, 8 mg, single-dose
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B: Active Comparator
Subjects received GlaxoSmithKine product under fasting conditions
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Drug: Zofran
ODT, 8 mg, fasting conditions
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To Compare the single-dose bioavailability of Kali's Ondansetron 8 mg ODT with that of GlaxoSmithKine's Zofran 8 mg ODT under fasting conditions
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Par Pharmaceutical, Inc. ( Dr. Alfred Elvin/ Director Biopharmacetics ) |
Study ID Numbers: | ODO-P2-158 |
First Received: | April 3, 2008 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00654277 |
Health Authority: | United States: Institutional Review Board |
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