Buprenorphine and Naloxone Combination Study - 10

This study has been completed.
Sponsor:
Collaborator:
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00015288
First received: April 18, 2001
Last updated: August 16, 2005
Last verified: August 1998

April 18, 2001
August 16, 2005
November 1996
Not Provided
  • Physiological measures
  • Measurements of buprenorphine and naloxone in plasma
  • Subjective symptoms measures
Same as current
Complete list of historical versions of study NCT00015288 on ClinicalTrials.gov Archive Site
Not Provided
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Buprenorphine and Naloxone Combination Study - 10
PK0496 Pharmacokinetics of Buprenorphine

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

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

Interventional
Phase 1
Masking: Double-Blind
Primary Purpose: Treatment
  • Heroin Dependence
  • Opioid-Related Disorders
Drug: Buprenorphine/naloxone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
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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.

Both
21 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00015288
NIDA-5-0013-10, Y01-5-0013-10
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
New York MDRU
Principal Investigator: John Rotrosen, M.D. New York MDRU
National Institute on Drug Abuse (NIDA)
August 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP