clinical trial · NCT00834873
Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects
Teva Pharmaceuticals USA·phase1·completed·n = 24
HealthyCarvedilol 25 mg tabletsCOREG® 25 mg tablets
brief summary
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 24 adult individuals under fed conditions.
started
Dec 1, 2001
primary completion
Dec 1, 2001
completion
Dec 1, 2001
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Randomized, Two-Way Crossover, Single-Dose, Open Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Carvedilol (25 mg), Compared to an Equivalent Dose of COREG® (SmithKline Beecham Pharmaceuticals) in 24 Fed, Healthy, Adult Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol