Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/13/2017 |
Start Date: | October 1997 |
End Date: | August 1999 |
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution
The purpose of this study is to compare subject response to liquid vs. tablet formulations,
to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to
evaluate if dose response curve for tablet is equal to liquid form."
to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to
evaluate if dose response curve for tablet is equal to liquid form."
1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of
liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet
= to liquid form
liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet
= to liquid form
Inclusion Criteria:
M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the
study and sign informed consent.
Exclusion Criteria:
Pregnant or nursing women. Acute medical condition that would interfere with study
participation or put safety of subjects in jeopardy. Current daily use of
anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics
dependence.
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