BIOEQUIVALENCE STUDY OF PROPRANOLOL TABLETS

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 (AUC^{0 to 24hr}, AUC^{0 to ∞} ,t_maxand Cp _max) were significantly different between treatments for the single dose data. Parameters of AUC^{0 to 24hr}of 630.4±285.0 ng.hr/ml vs 635.6±351.0 ng.hr/ml, AUC^{0 to ∞}, 670.2±299.2 ng.hr/ml vs 685.0±350.2 ng.hr/ml, t_max1.3±0.5 hr vs 1.6±0.8 hr and Cp_max115.3±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 AUC^{0 to 24hr}, AUC^{0 to ∞}and Cp _maxwere 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.