Title: PHARMACOKINETICS EVALUATION OF ACYCLOVIR IR 200 MG CAPSULE FORMULATIONS IN HEALTHY INDIAN ADULT VOLUNTEERS UNDER FASTING AND NON-FASTING CONDITIONS
Abstract: This study aimed to compare the systemic pharmacokinetics evaluations of test acyclovir IR 200mg capsule formulation compared with reference drug (Zovirax® 200mg IR Capsule), in healthy volunteers under fasting and non-fasting conditions with a single-dose, randomized, 2-period crossover study in healthy Indian adult volunteers, each subject received a single oral dose of either test or reference formulation followed by a 7-day washout period under fasting and non-fasting conditions. A serial of blood samples were collected over a period of 24 hours and plasma was separated and analyzed for acyclovir concentration using a validated LC-MS/MS liquid chromatography method with a lower limit of quantification of 5.0ng/mL. The formulations were to be considered bioequivalent if the log‐transformed ratios of Cmax, AUC0‐t, and AUC0‐∞, were within the predetermined bioequivalence range of 80% to 125%. There were no significance difference of mean values of AUC0-t, AUC0-∞, Cmax, Tmax and t1/2 following administration of the test and reference product for fasting and non-fasting conditions. No significant differences were found based on analysis of variance, with mean values and 90% confidence intervals of test/reference least square mean ratios for these parameters as follows: Cmax, 99.19% (95.09-107.86) versus 97.73% (92.27-110.89); AUC0‐t, 99.13% (96.27-103.51) versus 98.75% (98.81-112.11); and AUC0‐∞, 97.18% (92.88-100.94) versus 99.75% (99.07-114.60) ng.hr/mL under fasting versus non-fasting conditions, respectively. No serious adverse events were recorded, and there were no clinical significant changes in vital signs, clinical laboratory variables, ECG parameters or physical examination findings in both fasting and non-fasting study. In these healthy Indian volunteers, results suggested that the test and reference formulations of Acyclovir IR 200 mg capsules were within the acceptable range of 80 and 125 and bioequivalent, based on the regulatory definition under fasting and non-fasting conditions. Food did not significantly affect the Cmax or AUC0-t or AUC 0-∞ of acyclovir between test and reference products and were well tolerated.
Publication Year: 2011
Publication Date: 2011-01-01
Language: en
Type: article
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