MedTrace Logo

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole

NCT01259115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-05-19

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.

Conditions

  • Healthy

Interventions

DRUG

Buprenorphine transdermal patch

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

DRUG

Ketoconazole tablet

Ketoconazole 200 mg tablets taken orally twice daily.

DRUG

Placebo to match ketoconazole tablet

Placebo to match ketoconazole 200 mg tablets taken orally twice daily.

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2003-06-30
Completion
2003-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01259115 on ClinicalTrials.gov