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The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers

NCT01148537 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2012-09-03

Study results available
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Summary

The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h.

DRUG

Matching placebo transdermal patch

Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20.

DRUG

Avelox (moxifloxacin hydrochloride) tablet

Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2004-12-31
Completion
2004-12-31

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 NCT01148537 on ClinicalTrials.gov