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

Merck Sharp & Dohme (MSD) logo

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)

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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