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Rezumat articol ediţie STUDIA UNIVERSITATIS BABEŞ-BOLYAI
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Rezumat: The objective of the study was to determine in vitro – in vivo correlations for Gliclazide 60 mg modified release tablets developed by Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries Limited, India, based on the data obtained in two bioequivalence clinical trials and in in vitro dissolution tests. Each clinical trial was designed as an open-label, randomized, single-dose, crossover study that consisted of two periods. The first bioequivalence study was performed under the fasting state of the subjects, while the second bioequivalence study was carried out under the fed state of the subjects. During each study period, venous blood samples were taken pre-dose and post-dose up to 96 hours. Afterwards, individual plasma profiles were obtained and mathematical deconvolution was applied to obtain the relative fraction absorbed of gliclazide. These data were correlated with the in vitro dissolution data obtained after performing dissolution tests in three different dissolution media, at pH 4.5, 6.8 and 7.2, with Gliclazide 60 mg modified release tablets (EvoluPharm, France). All calculation were performed by Phoenix WinNonlin® version 6.3. For each in vivo data set from the bioequivalence studies (under fasting and fed conditions), three level A in vitro-in vivo correlations were obtained for Gliclazide 60 mg modified release tablets, for in vitro tests performed at pH 4.5, 6.8, and 7.2. Good correlation coefficients were found for each established correlation (R2=0.98-0.99). In conclusion, six level A in vitro-in vivo correlations were obtained for Gliclazide 60 mg modified release tablets manufactured by Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries Limited, India.
Keywords: gliclazide, in vitro-in vivo correlations, clinical trial, healthy Caucasian subjects |
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