Buprenorphine and Naloxone Combination Study - 10
This study has been completed.
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)
First received: April 18, 2001
Last updated: August 16, 2005
Last verified: August 1998
The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.
Primary Purpose: Treatment
||PK0496 Pharmacokinetics of Buprenorphine
Primary Outcome Measures:
- Physiological measures
- Measurements of buprenorphine and naloxone in plasma
- Subjective symptoms measures
| Estimated Enrollment:
| Study Start Date:
The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.
|Ages Eligible for Study:
||21 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015288
|New York MDRU
|New York, New York, United States, 10010 |
New York MDRU
||John Rotrosen, M.D.
||New York MDRU
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 18, 2001
||August 16, 2005
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents