NCT02268422

Bioequivalence and Adhesion Comparison of Buprenorphine Patches

A Two-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Bioequivalence and Adhesion of Buprenorphine Transdermal System Second Generation Patch Compared With First Generation Patch, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of drug) and that they equally both stick to the skin over 7 days of continuous wear.

Detailed description

The objective is to compare a 2nd generation BTDS patch 20 µg/h to the 1st generation patch to confirm bioequivalence. Determination will be via measurement of drug concentrations in the blood at serial collection time points pre-dose until 288 hours post-patch application. Approximately 100 healthy male and female volunteers will receive both BTDS patches across two study periods with a 14-day wash-out between applications. Each patch will be worn for 7 consecutive days and the study will also review the adhesion of each patch to the skin of the subjects. The overall safety and tolerability of both patches will be assessed.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine	7 day patch

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2015-10-01
• First posted: 2014-10-20
• Last updated: 2016-02-09

Locations

2 sites across 1 country: United Kingdom