Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972595
• Other study ID #: 0869-106
• Secondary ID: MK0869-1062009_6
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2009
• Last updated: August 18, 2015
• Start date: June 2004
• Est. completion date: September 2004

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• If female, subject is not pregnant or breast-feeding

• Subject has been a nonsmoker for at least 6 months

• Subject is in good health

Exclusion Criteria:

• Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease

• Subject is a habitual and heavy consumer of caffeine

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting

Intervention

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.
• ondansetron marketed formulation
Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron		0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose	No
Primary	Peak Plasma Concentration (Cmax) for Ondansetron		24 hours post-dose	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site