Premium
PIII‐80
Author(s) -
Borges N.,
Mendes G.,
De Nucci G.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.288
Subject(s) - geometric mean , bioequivalence , cmax , carvedilol , medicine , pharmacology , crossover study , confidence interval , mathematics , pharmacokinetics , statistics , placebo , heart failure , alternative medicine , pathology
METHODS Thirty six healthy volunteers as assessed by clinical and laboratory test evaluations, were enrolled in the study. The study was a single dose, two‐way randomized crossover design comparing Carvedilol tablet formulations. Plasma samples for determination of Carvedilol were obtained pre‐dose and at frequent intervals for up to 36h post‐dose. Carvedilol plasma concentrations were quantified by a validated method employing LC‐MS‐MS. The subjects were monitored throughout the study. Systolic and diastolic blood pressure and pulse rate measurement were taken pre‐dose and at intervals up to 36h. Tolerance of both products was good. RESULTS The (C max ), the (AUC last ), the (AUC 0–36h ) and (AUC inf(observed) ) were compared. Carvedilol 25 mg test tablet C max geometric mean ratio was 97.22%, AUC last geometric mean ratio was 95.18%, AUC 0–36h geometric mean ratio was 95.25%, AUC inf geometric mean ratio was 95.13%. Carvedilol 25mg reference tablet C max geometric mean ratio was 97.22%, AUC last geometric mean ratio was 94.77%, AUC 0–36h geometric mean ratio was 94.79%, AUC inf geometric mean ratio was 94.74%. CONCLUSION Since the 90% CI for C max and AUC last ratios were inside the 80–125% interval proposed by the FDA, it is concluded Carvedilol 25 mg tablet test formulation is bioequivalent to Coreg® 25 mg tablet formulation for both the rate and the extent of absorption.Clinical Pharmacology & Therapeutics (2005) 79 , P81–P81; doi: 10.1016/j.clpt.2005.12.288