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Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01148537

Public ClinicalTrials.gov record NCT01148537. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo- & Positive-Controlled, Parallel Group, Dose Escalating Study to Evaluate the Effect of Buprenorphine Delivered by Buprenorphine Transdermal System at 10- and 40-mg Dose Levels on QT Intervals in Healthy Adult Volunteers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01148537
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Purdue Pharma LP
Industry
Enrollment
132 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2004
Primary completion
Nov 30, 2004
Completion
Nov 30, 2004
Last update posted
Sep 2, 2012

2004

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
PPD Development, LP, Clinics Austin Texas 78704

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01148537, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 2, 2012 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01148537 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →