A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Second generation BTDS patch; Drug: First generation BuTrans patch

• Registration Number: NCT02160067
• Lead Sponsor: Mundipharma Research Limited

Brief Summary

The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation BTDS patches.

Detailed Description

The objective is to examine a new 2nd generation BTDS patch formulation at 2 strengths: 3.15 mg and 12.6 mg, compared to 1st generation patches at 2 strengths: 5 mg and 20 mg, to assess dose proportionality and relative bioavailability before proceeding to a definitive program of studies. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 288 hours post-patch application.

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-10
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Second generation BTDS patch	Second generation patch BTDS 12.6mg
Treatment D	First generation BuTrans patch	First generation patch BuTrans 5mg
Treatment C	First generation BuTrans patch	First generation patch BuTrans 20mg
Treatment B	Second generation BTDS patch	Second generation patch BTDS 3.15mg

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters	Up to 288 hours	AUC and Cmax

Secondary Outcome Measures

Name	Time	Method
Adverse events	7 to 10 days	AEs will be recorded through spontaneous reporting

Trial Locations

Locations (1)

Quotient Clinical Ltd; 🇬🇧 Nottingham, United Kingdom