Bioequivalence Study Of Propranolol Tablets
More details
Hide details
University Sains Malaysia, The School of Medical Sciences, Department of Pharmacology, Kelantan, Malaysia
Online publication date: 2004-10-15
Publication date: 2004-10-15
Corresponding author
Zabidah Ismail   

BPharm (Hons), MPharm, PhD, Associate Professor, Pharmacology Department, The School of Medical Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian Kelantan, MALAYSIA Tel: 609-766 4707/012 291 2767
Eur J Gen Med 2004;1(4):42-47
The purpose of this study is to compare the bioavailability of a test tablet of propranolol (RAZA propranolol, Pharmaniaga) against an innovator product (Inderal, Astra Zeneca). The study was performed in eighteen healthy male volunteers for a single 2 x 40 mg dose of propranolol tablets. The study design used was a randomized, double blind two-period crossover design. Blood samples were collected before and within 24 hours after drug administration and plasma propranolol concentration was determined using HPLC method. Statistical analysis of the propranolol data indicated that none of the accepted parameters for drug bioavailability (AUC0 to 24hr, AUC0 to ∞ ,tmax and Cp max ) were significantly different between treatments for the single dose data. Parameters of AUC0 to 24hr of 630.4±285.0 ng.hr/ml vs 635.6±351.0 ng.hr/ml, AUC0 to ∞ , 670.2+299.2 ng.hr/ml vs 685.0+350.2 ng.hr/ml, tmax 1.3±0.5 hr vs 1.6±0.8 hr and Cpmax 115.3±53.4 ng/ml vs 117.5±77.3 ng/ml were obtained with test and reference formulations respectively. The 95% confidence interval of the log of ratio of AUC0 to 24hr, AUC0 to ∞ and Cp max were within the range of 0.80-1.25. It can be indicated that the two tablet dosage forms (i.e. RAZA and Inderal) showed similar bioavailability and are therefore considered bioequivalent.
Journals System - logo
Scroll to top