Trials / Completed
CompletedNCT00972595
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ondansetron clinical trial formulation | Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods. |
| DRUG | ondansetron marketed formulation | Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods. |
Timeline
- Start date
- 2004-06-01
- Primary completion
- 2004-08-01
- Completion
- 2004-09-01
- First posted
- 2009-09-07
- Last updated
- 2015-08-19
- Results posted
- 2010-06-22
Source: ClinicalTrials.gov record NCT00972595. Inclusion in this directory is not an endorsement.