NCT03975010

Buprenorphine Transdermal Patches Pharmacokinetic Study

An Open-label, Randomized, Single-dose, Parallel-group Study to Investigate the PK Profile of Single Dose Buprenorphine Transdermal Patch 20 mg Applied for 3 Days, 40 mg for 3 Days and 40 mg for 4 Days in Chinese Subjects With Chronic Pain

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomised, single-dose, 3 arms study design.

Detailed description

Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine Transdermal Patch	This is an open-label, randomised, single-dose, 3 arms study design. Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days. Safety follow-up will be planned at 7\~9 days after patch removal. The study patch will be applied under the cover of naltrexone to reduce opioid related side-effects. Naltrexone 50 mg will be taken orally every 12 hours, from the evening of Day 00 (13 hours prior to IMP application), until the evening of the patch removal.

Timeline

• Start date: 2019-05-13
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-06-05
• Last updated: 2019-06-05

Locations

1 site across 1 country: China