The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least 10 hours.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
8 mg Sublingual Tablets
8 mg Sublingual Tablets
CEDRA Clinical Research, LLC
Austin, Texas, United States
Cmax of Buprenorphine.
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).
Time frame: Blood samples collected over a 144 hour period.
AUC0-t for Buprenorphine.
Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Time frame: Blood samples collected over a 144 hour period.
AUC0-inf for Buprenorphine.
Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Time frame: Blood samples collected over a 144 hour period.
Cmax for Norbuprenorphine.
Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.
Time frame: Blood samples collected over a 144 hour period.
AUC0-t for Norbuprenorphine.
Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.
Time frame: Blood samples collected over a 144 hour period.
AUC0-inf for Norbuprenorphine.
Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.
Time frame: Blood samples collected over a 144 hour period.
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