Buprenorphine and Naloxone Combination Study - 10

PK0496 Pharmacokinetics of Buprenorphine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00015288

Enrollment

Registered

2001-04-18

Start date

1996-11-30

Completion date

Unknown

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Dependence, Opioid-Related Disorders

Brief summary

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

Detailed description

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

Interventions

DRUGBuprenorphine/naloxone

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
Physiological measures	—
Measurements of buprenorphine and naloxone in plasma	—
Subjective symptoms measures	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026