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NCT01259102 · ClinicalTrials.gov registry record · Phase 1
Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
A Phase 1 study of Healthy, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01259102: Completed Phase 1 study of Healthy, sponsored by Purdue Pharma.
NCT01259102 is a Phase 1 study of Healthy that has completed, run by Purdue Pharma. The registered enrollment target is 70 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259102, a Phase 1 study of Healthy, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.
Primary Outcome
Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d \[The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)\].
Conditions Studied
Interventions
- DRUG Buprenorphine transdermal patch
Study Locations (1)
Ohio
- The Ohio State University Department of Pharmacology - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2000-11 |
| Est. Completion | 2001-03 |
| Phase | Phase 1 |
What the finished NCT01259102 record still lists
NCT01259102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.
NCT01259102 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01259102 about?
NCT01259102 is a clinical study titled "Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods". The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.
What is the current status of trial NCT01259102?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2000-11. Estimated completion is 2001-03.
What conditions does trial NCT01259102 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01259102?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT01259102?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01259102 being conducted?
This trial has 1 study location across Ohio. 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 NCT01259102's enrollment target sits among peer trials
70 325th of 1090 higher than 759 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.
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