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Abstract
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.
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Article Type: Original Article
EUR J GEN MED, Volume 1, Issue 4, October 2004, 42-47
https://doi.org/10.29333/ejgm/82227
Publication date: 15 Oct 2004
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Article Downloads: 1341
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