The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals) in a test population of 36 adult individuals under fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
1 x 25 mg
1 x 25 mg
Gateway Medical Research, Inc.
Saint Charles, Missouri, United States
Cmax - Maximum Observed Concentration - Carvedilol in Plasma
Bioequivalence based on Cmax
Time frame: Blood samples collected over 60 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma
Bioequivalence based on AUC0-inf
Time frame: Blood samples collected over 60 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 60 hour period
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