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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Algorithme Pharma Inc |
Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00659074 |
Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 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, Factorial Assignment |
Official Title: | Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 24 mg ODT With That of GlaxoSmithKine's Zofran 24 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions |
Enrollment: | 24 |
Study Start Date: | October 2003 |
Study Completion Date: | February 2004 |
Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Ondansetron ODT
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Drug: Ondansetron
ODT, single-dose, fasting
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B: Active Comparator
Zofran ODT
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Drug: Zofran
ODT, single-dose, fasting
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To Compare the single-dose bioavailability of Kali's Ondansetron 24 mg ODT with that of GlaxoSmithKine's Zofran 24 mg ODT under fasting conditions
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Par Pharmaceutical, Inc. ( Dr. Alfed Elvin/ Director Biopharmaceutics ) |
Study ID Numbers: | ODO-P3-266 |
First Received: | April 10, 2008 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00659074 |
Health Authority: | United States: Institutional Review Board |
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