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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: December 2003

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Treatment Sequence A-B-C
• Experimental: 2
  • Treatment Sequence B-C-A
• Experimental: 3
  • Treatment Sequence C-A-B
• Experimental: 4
  • Treatment Sequence A-C-B
• Experimental: 5
  • Treatment Sequence B-A-C
• Experimental: 6
  • Treatment Sequence C-B-A

Primary Measures

• Area under the concentration versus time curve (AUC(0-infinity) for ondansetron
  • Time Frame: 24 hours post dose
    Safety Issue?: No
• Maximum plasma concentration (Cmax) of ondansetron
  • Time Frame: 24 hours post dose
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00971633

Study ID Number: 2009_656

ClinicalTrials.gov Identifier: NCT00971633

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site