NCT05027646

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

A Randomized, Open-Label, Replicate Treatment, 2-Part, Crossover Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches Manufactured at Different Sites.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects to establish bioequivalence (Part 1) and evaluate adhesion (Part 2) between granisetron transdermal patches manufactured at 2 different sites (Sancuso \[test\] and Sancuso \[reference\]). Each part of the study will consist of a screening period, check-in days, treatment periods, washout period (Part 1 only), and an end-of-study visit. The duration of subject participation, excluding screening, for Part 1 is approximately 39 days and for Part 2 is approximately 17 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Sancuso - Part 1	Part 1 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
DRUG	Sancuso - Part 2	Part 2 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.

Timeline

• Start date: 2021-07-06
• Primary completion: 2021-12-22
• Completion: 2022-01-19
• First posted: 2021-08-30
• Last updated: 2024-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study