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NCT01259115 · ClinicalTrials.gov registry record · Phase 1
Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
A Phase 1 study of Healthy, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01259115: Completed Phase 1 study of Healthy, sponsored by Purdue Pharma.
NCT01259115 is a Phase 1 study of Healthy that has completed, run by Purdue Pharma. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259115, a Phase 1 study of Healthy, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.
Primary Outcome
AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily. Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (20
Conditions Studied
Interventions
- DRUG Buprenorphine transdermal patch
- DRUG Ketoconazole tablet
- DRUG Placebo to match ketoconazole tablet
Study Locations (1)
Louisiana
- Clinical Research Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2002-10 |
| Est. Completion | 2003-06 |
| Phase | Phase 1 |
What the finished NCT01259115 record still lists
NCT01259115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT01259115 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT01259115 about?
NCT01259115 is a clinical study titled "Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole". The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.
What is the current status of trial NCT01259115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2002-10. Estimated completion is 2003-06.
What conditions does trial NCT01259115 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01259115?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Ketoconazole tablet (DRUG), Placebo to match ketoconazole tablet (DRUG).
Who is sponsoring clinical trial NCT01259115?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01259115 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01259115's enrollment target sits among peer trials
20 861st of 1090 higher than 194 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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