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
| Tracking Information | |||||
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| First Received Date ICMJE | April 18, 2001 | ||||
| Last Updated Date | August 16, 2005 | ||||
| Start Date ICMJE | November 1996 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00015288 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Buprenorphine and Naloxone Combination Study - 10 | ||||
| Official Title ICMJE | PK0496 Pharmacokinetics of Buprenorphine | ||||
| Brief Summary | The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone. |
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| Detailed Description | The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Buprenorphine/naloxone | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 21 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00015288 | ||||
| Other Study ID Numbers ICMJE | NIDA-5-0013-10, Y01-5-0013-10 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | New York MDRU | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | August 1998 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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