Trials / Completed
CompletedNCT01260675
Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone
A Study to Assess the Pharmacokinetic Profile of an Investigational Formulation of Buprenorphine HCl/Naloxone HCl 8mg/2mg Capsules Relative to the Pharmacokinetic Profile of Suboxone® (Buprenorphine HCl/Naloxone HCl 8mg/2mg Sublingual Tablets).
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- NanoSHIFT LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.
Detailed description
The pharmacokinetics of an orally administered investigational buprenorphine hydrochloride/naloxone hydrochloride 2 mg/0.5 mg capsule formulation will be studied. This is a single-dose, two period, two treatment, crossover comparative bioavailability study under fasting conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buprenorphine HCl/Naloxone HCl |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-31
- First posted
- 2010-12-15
- Last updated
- 2017-06-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01260675. Inclusion in this directory is not an endorsement.