Overview

Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.

Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
The study is designed to evaluate the BE and adhesion properties of granisetron transdermal patches manufactured at 2 different sites. The study has been designed in accordance with the FDA Guidance for Industry. Bioequivalence will be based on the Cmax and AUC to determine the peak and total drug exposure, respectively.
Phase:
Phase 1
Details
Lead Sponsor:
Kyowa Kirin, Inc.
Collaborator:
PPD
Treatments:
Granisetron