Abstract

FOOD EFFECT ASSESSED ON BIOAVAILABILITY OF VALSARTAN IN INDIAN POPULATION

Ashvin M. Patel*, Falguni Majmudar, Naveen Sharma, Bhavin N. Patel

ABSTRACT

Food effect on pharmacokinetic parameters of Valsartan was assessed by evaluating data of reference product Valsartan 320 mg tablet from two bio-equivalence studies. 30 male healthy subjects participated in the fasting and non fasting study. Drug was administrated after 12h fasting and about 30 minutes after serving of standardized high-fat & high-calorie breakfast in fasting and non fasting condition respectively. Serially blood samples were collected from time of dosing to 36h of post dosing. Blood samples were analysed for the concentration of the Valsartan by using validated LC/MS/MS technique. Food intake increased Cmax of Valsartan by about 27% and increases AUCt and AUCi of Valsartan by about 11%. 90% confidence interval of Valsartan for Cmax, AUCt and AUCi are not within limit (80% to 125%). Which indicates efficacy (bioavailability) of Valsartan is affected by presence of food.

Keywords: Valsartan; food effect; Pharmacokinetics; bioavailability.