Trials / Terminated
TerminatedNCT00768482
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
A Single Cross-Over, Open-Label Study of the Relative Bioavailability of Probuphine Versus Buprenorphine Sublingual Tablets at Steady State in Patients With Opioid Dependence
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Titan Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
Detailed description
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Probuphine (buprenorphine implant) | Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants) |
| DRUG | Sublingual Buprenorphine | 16 mg/day, QD |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-10-08
- Last updated
- 2018-12-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00768482. Inclusion in this directory is not an endorsement.