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Buprenorphine Transdermal Patches Pharmacokinetic Study

NCT03975010 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-06-05

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Mundipharma (China) Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Wenping Wang, PhD · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03975010 on ClinicalTrials.gov