A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Famotidine 40mg tablet of Amin Pharm Co., IRAN in comparison of Famodin® 40mg tablet of Sandoz in 24 healthy adult subjects under fasting condition

A randomized, crossover bioequivalence study of single dose of test formulation (one tablet of Famotidine 40mg produced by Amin Pharm Co., IRAN in comparison of reference product (one tablet of Famodin® 40mg) by means of AUC0-t and Cmax in healthy adult human subjects under fasting conditions.

A randomized, open label, single dose, crossover, bioequivalence study in 24 healthy subjects under fasting condition

This study is carried out in Core Research Center of Zahedan University of Medical Sciences located in Imam Ali Hospital in Zahedan. There is a separate space for sampling and forecasting emergency situations in order to accommodate and rest the volunteers. This crossover and open label study was performed on 24 healthy volunteers. The volunteers' health is verified by the project physician prior to entry into the study, and the volunteers' status is regularly monitored by the project physician on the day of drug

Main Inclusion criteria: Healthy subjects aged between 18 -50 years old and weighted between 50 – 100 kg\\ Main exclusion criteria: Clinically relevant deviations from normal; Donation a unit of blood or participated in another clinical trial within the last two months; History of drug or alcohol abuse; Used any medication within 7- 14 days before the first treatment;

Intervention: Single dose of one Famotidine 40mg tablet of Amin Pharm Co., IRAN Control: Single dose of one Famodin® 40mg tablet of Sandoz

Plasma concentration of Famotidine at 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 & 10.0 hr. after dosing

Using Excel software, each subject randomly assigned to one of the two sequence AB or BA in a balanced manner.