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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01259115
The ClinicalTrials.gov registry entry for NCT01259115 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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