Buprenorphine and Naloxone Combination Study - 10

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Heroin Dependence; Opioid-Related Disorders

Treatments: Drug: Buprenorphine/naloxone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00015288

Y01-5-0013-10

NIDA-5-0013-10

Details and patient eligibility

About

The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Full description

The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent.

Exclusion criteria

LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.