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The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers

NCT01999114 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2018-11-05

Study results available
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Summary

The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.

Conditions

  • ECG Effects

Interventions

DRUG

Buprenorphine transdermal patch

Buprenorphine patch applied transdermally

DRUG

Naltrexone tablet

Naltrexone tablet; 1 tablet taken orally every 12 hours

DRUG

Placebos (for TDS and for naltrexone and for moxifloxacin)

Matching placebos

DRUG

Moxifloxacin tablet

Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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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 NCT01999114 on ClinicalTrials.gov