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An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:
An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

Clinical Trial Summary

This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects.

Clinical Trial Description

To assess the bioequivalence of a single oral dose of 200 mg rolapitant and a single intravenous dose of 185 mg rolapitant administered as an infusion. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02285647
Study type Interventional
Source Tesaro, Inc.
Contact
Status Completed
Phase Phase 1
Start date September 2014
Completion date May 2015
View Details
See also
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