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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chemotherapy-Induced Nausea and Vomiting

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971633

0869-095

2009_656

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 6 patient groups

1

Experimental group

Description:

Treatment Sequence A-B-C

Treatment:

Drug: Comparator: Treatment C (Zofran, ondansetron)

Drug: Comparator: Treatment A (Zofran, ondansetron)

Drug: Comparator: Treatment B (Zofran, ondansetron)

2

Experimental group

Description:

Treatment Sequence B-C-A

Treatment:

Drug: Comparator: Treatment C (Zofran, ondansetron)

Drug: Comparator: Treatment A (Zofran, ondansetron)

Drug: Comparator: Treatment B (Zofran, ondansetron)

3

Experimental group

Description:

Treatment Sequence C-A-B

Treatment:

Drug: Comparator: Treatment C (Zofran, ondansetron)

Drug: Comparator: Treatment A (Zofran, ondansetron)

Drug: Comparator: Treatment B (Zofran, ondansetron)

4

Experimental group

Description:

Treatment Sequence A-C-B

Treatment:

Drug: Comparator: Treatment C (Zofran, ondansetron)

Drug: Comparator: Treatment A (Zofran, ondansetron)

Drug: Comparator: Treatment B (Zofran, ondansetron)

5

Experimental group

Description:

Treatment Sequence B-A-C

Treatment:

Drug: Comparator: Treatment C (Zofran, ondansetron)

Drug: Comparator: Treatment A (Zofran, ondansetron)

Drug: Comparator: Treatment B (Zofran, ondansetron)

6

Experimental group

Description:

Treatment Sequence C-B-A

Treatment:

Drug: Comparator: Treatment C (Zofran, ondansetron)

Drug: Comparator: Treatment A (Zofran, ondansetron)

Drug: Comparator: Treatment B (Zofran, ondansetron)