Trials / Completed
CompletedNCT00971633
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (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 U.S. and non-U.S. marketed formulation of ondansetron.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Comparator: Treatment A (Zofran, ondansetron) | an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO) |
| DRUG | Comparator: Treatment B (Zofran, ondansetron) | a single 8 mg tablet of Zofran marketed in the U.K., taken PO |
| DRUG | Comparator: Treatment C (Zofran, ondansetron) | a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2003-12-01
- Completion
- 2004-01-01
- First posted
- 2009-09-04
- Last updated
- 2016-09-14
- Results posted
- 2010-08-26
Source: ClinicalTrials.gov record NCT00971633. Inclusion in this directory is not an endorsement.