A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971633
• Other study ID #: 0869-095
• Secondary ID: 2009_656
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2009
• Last updated: September 13, 2016
• Start date: November 2003
• Est. completion date: January 2004

Study information

• Verified date: September 2016
• 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 U.S. and non-U.S. marketed formulation of ondansetron.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2004
• Est. primary completion date: December 2003
• 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 is a nonsmoker

• Subject is in good general health

Exclusion Criteria:

• Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease

• Subject is taking prescription or nonprescription drugs that can not be discontinued during the study

• 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
• Vomiting

Intervention

Drug:
• Comparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
• Comparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
• Comparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO

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	Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron		0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose	No
Primary	Maximum Plasma Concentration (Cmax) of Ondansetron		24 hours post dose	No

External Links

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