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Bioavailability Section

Comparative bioavailability study of two salbutamol tablets in healthy adult volunteers

Z. Chik, R.C. Basu, R. Pendek, T.C. Lee and Z. Mohamed

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Volume 47 p. 413 - 418

Abstract

Z. Chik¹, R.C. Basu¹, R. Pendek², T.C. Lee³ and Z. Mohamed¹

¹Department of Pharmacology, ²Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur and ³Info Kinetic Sdn. Bhd., University Science Malaysia, Penang, Malaysia
This study was carried out to compare the rate and extent of absorption of a generic salbutamol in oral dosage form (Brethmol, 4mg) with the proprietary equivalent product (Ventolin^®, 4mg), in healthy adult subjects, under fasting conditions. The study was a single dose, randomized, two way crossover study with a four-week washout period. It involved 22 healthy volunteers who received a single dose (4mg) of the test and the reference products after an overnight fast of at least 10 hours. Blood samples were collected at pre-dose and a serial of 14 samples were collected from each of the subject from 1h until 48 h post-dose. Plasma concentrations of salbutamol were analyzed using GCMS method. The mean AUC_0-¥ values were 91.26 and 96.45 h.ng/ml for reference and test product, respectively. The mean C_max values were 12.26 and 12.38 ng/ml and the mean t_max values were 2.80 and 2.33 hours for reference and test product, respectively. Analysis of variance showed that the 90% confidence intervals on the relative difference of the ratio for the AUC_0-¥ and the C_max for the test and reference products were contained within the bioequivalence limit (80 – 125%) (C_max: 89.8 – 110.5% and AUC_0-¥: 91.6 – 121.5%). There was no statistically significant difference for the t_max between the test and reference formulations (p = 0.30). The test formulation was found to be bioequivalent to the reference formulation with regard to AUC_0-¥ and C_max. There was no statistically significant difference in Brethmol and Ventolin^® t_max. In conclusion, Brethmol and Ventolin^® are bioequivalent in healthy subjects.Correspondence to:
Z. Chik
Department of Pharmacology
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Email: [email protected]

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