Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone
Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.
|Official Title:||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).|
- pharmacokinetic profile of NanoBUP Capsules relative to Suboxone [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Investigational Formulation of Buprenorphine HCl/Naloxone HCl 8 mg/2 mg oral capsules
Suboxone Sublingual Tablets
Buprenorphine HCl/Naloxone HCl 8 mg/2 mg sublingual tablets
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.
|United States, Texas|
|Worldwide Clinical Trials|
|San Antonia, Texas, United States, 78217|
|Principal Investigator:||Michael Natalino, MD||Worldwide Clinical Trials|