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NCT00015288 Clinical Trial

Buprenorphine and Naloxone Combination Study - 10

Opioid-Related Disorders Clinical Trial

Official title:
PK0496 Pharmacokinetics of Buprenorphine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00015288
Other study ID # NIDA-5-0013-10
Secondary ID Y01-5-0013-10
Status Completed
Phase Phase 1
First received April 18, 2001
Last updated January 11, 2017
Start date November 1996

Study information
Verified date August 1998
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility 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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine/naloxone

Locations
Country Name City State
United States New York MDRU New York New York

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) New York MDRU

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physiological measures
Primary Measurements of buprenorphine and naloxone in plasma
Primary Subjective symptoms measures
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