[PDF][PDF] Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy Malaysian volunteers

K Jiyauddin, H Kah, H Bee, W Jia… - … American Journal of …, 2011 - researchgate.net
K Jiyauddin, H Kah, H Bee, W Jia, ALD Samer, GO Elhassan, M Chitneni, K Mohammed…
Latin American Journal of Pharmacy, 2011researchgate.net
The aim of this study was to evaluate the in vivo behavior of matrix tablets formulated with
ketoprofen as a model drug after oral administrations in healthy Malaysian male volunteers
and to compare its rate and extent of absorption with the commercially available tablet Apo-
Keto SR® as a reference product. The test formulation containing 20% HPC (GXF) as
release retardant was selected in this regard. The bioequivalence study was conducted
according to a single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study …
Summary
The aim of this study was to evaluate the in vivo behavior of matrix tablets formulated with ketoprofen as a model drug after oral administrations in healthy Malaysian male volunteers and to compare its rate and extent of absorption with the commercially available tablet Apo-Keto SR® as a reference product. The test formulation containing 20% HPC (GXF) as release retardant was selected in this regard. The bioequivalence study was conducted according to a single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study design on six healthy non-smoking Malaysian adult male volunteers. Plasma concentrations of ketoprofen were determined by a high-performance liquid chromatographic method with UV detection. The pharmacokinetic parameters, Tmax, Cmax, AUC0–∞, Ke, and T1/2 were determined. The 90% confidence intervals of the mean values for the test/reference ratios were 96.89-107.03% for AUC0–∞ and 99.64-104.62% for Cmax, respectively. The results of this study suggest that the two preparations, the test formulation of ketoprofen 200 mg tablets were bioequivalent to the marketed reference tablet of Apo-Keto SR® 200 mg in these healthy Malaysian male volunteers. However, this study results are to be further confirmed by carrying out a pivotal biostudy using more number of subjects.
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