food effect

For the assessment effect of food on the pharmacokinetic parameters of Hydrochlorothiazide(HCTZ) data of reference product (12.5 mg capsule) from two bio-equivalence studies were combined and evaluated. 36 male healthy subjects participated in the fasting and non fasting study. Subjects received the drug product after 12 hours(h) overnight fast for the fasting study and after 30.0 minutes of high fat  breakfast for the non-fasting study. Blood samples were collected from time of dosing to 60 h of the post dosing at predefined time. Blood samples were analyzed for the concentration of the HCTZ by using validated LC/MS/MS technique. Food decrease the Cmax by about 28% and AUC by about 9%. While Tmax was delayed about 97%(from 2.185h to 4.320h). food prolonged the mean resident time of HCTZ.