Conditions: Chemotherapy-Induced Nausea and Vomiting
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: Treatment Sequence A-B-C arm 2: Treatment Sequence B-C-A arm 3: Treatment Sequence C-A-B arm 4: Treatment Sequence A-C-B arm 5: Treatment Sequence B-A-C arm 6: Treatment Sequence C-B-A

Interventions: intervention 1: Comparator: Treatment A (Zofran, ondansetron) intervention 2: Comparator: Treatment B (Zofran, ondansetron) intervention 3: Comparator: Treatment C (Zofran, ondansetron)
Intervention descriptions: intervention 1: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO) intervention 2: a single 8 mg tablet of Zofran marketed in the U.K., taken PO intervention 3: a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO

Protocol document: