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

NCT00971633 | Completed Phase 1 Results

• 2 other identifiers: 0869-0952009_656
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Chemotherapy-Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• 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

• Maximum Plasma Concentration (Cmax) of Ondansetron

  24 hours post dose

Study Arms (6)

1

EXPERIMENTAL

Treatment Sequence A-B-C

Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

2

EXPERIMENTAL

Treatment Sequence B-C-A

Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

3

EXPERIMENTAL

Treatment Sequence C-A-B

Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

4

EXPERIMENTAL

Treatment Sequence A-C-B

Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

5

EXPERIMENTAL

Treatment Sequence B-A-C

Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

6

EXPERIMENTAL

Treatment Sequence C-B-A

Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

Interventions

Comparator: Treatment A (Zofran, ondansetron) DRUG

an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)

Also known as: Zofran, ondansetron

1; 2; 3; 4; 5; 6

Comparator: Treatment B (Zofran, ondansetron) DRUG

a single 8 mg tablet of Zofran marketed in the U.K., taken PO

Also known as: Zofran, ondansetron

1; 2; 3; 4; 5; 6

Comparator: Treatment C (Zofran, ondansetron) DRUG

a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO

Also known as: Zofran, ondansetron

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If female, subject is not pregnant or breast-feeding
• Subject is a nonsmoker
• Subject is in good general health

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Executive Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: November 1, 2003
• Primary Completion: December 1, 2003
• Study Completion: January 1, 2004
• Last Updated: September 14, 2016
• Results First Posted: August 26, 2010

Record last verified: 2016-09