Piush Sharma
India
Research Article
Comparative Pharmacokinetics, Safety and Tolerability Evaluation of
Acyclovir IR 800 Mg Tablet in Healthy Indian Adult Volunteers Under
Fasting and Non-fasting Conditions
Author(s): P Susantakumar, Ajay Gaur and Piush SharmaP Susantakumar, Ajay Gaur and Piush Sharma
Objectives: This study was designed to determine the comparative pharmacokinetics, safety and tolerability of test acyclovir 800mg IR formulation with reference product (Zovirax® 800mg IR Tablet) after single dose administration under fasting and non-fasting conditions in 36 male and female adult subjects. Methods: Open label, balanced, randomized, two-sequence, single-dose, two-way crossover study design in healthy Indian adult volunteers with a washout period of at least 7 days was used. Each subject received an acyclovir test or reference product respectively. Blood samples were collected before dosing and at various time points up to 24 hours after dosing. Plasma samples were analyzed by validated liquid chromatography with tandem mass spectrometry method. The pharmacokinetic parameters C max , T max , MRT, AUC 0-t , and AUC 0-∞ were analyzed using non-compartment model... View More»
DOI:
10.4172/jbb.1000073