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NCT01157169 · ClinicalTrials.gov registry record · Phase 1
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01157169: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01157169 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01157169, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least 10 hours.
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-08 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01157169
The ClinicalTrials.gov registry entry for NCT01157169 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Pharmaceuticals USA, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine is the first listed.
NCT01157169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01157169 about?
NCT01157169 is a clinical study titled "Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions". The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Ben...
What is the current status of trial NCT01157169?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-08. Estimated completion is 2007-09.
What interventions are being tested in trial NCT01157169?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01157169?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
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