A randomized, open label, single dose, crossover, bioequivalence study of Fexofenadine 120mg tablet of Jaber Ebne Hayyan Pharm. Co., IRAN in comparison of Telfast 120mg tablet of Sanofi in 24 healthy adult subjects under fasting condition

A randomized, crossover bioequivalence study of single dose of test formulation (Fexofenadine 120mg tablet of Jaber Ebne Hayyan Pharm. Co.) in comparison of reference product (Telfast 120mg tablet ) by means of AUC0-t (Area Under the Curve up to the last measurable concentration) and Cmax (maximum plasma concentration) 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 administration. This study will be covered by insurance in order to compensate for any adverse effects.

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 two Fexofenadine 120mg tablets of Jaber Ebne Hayyan Pharm. Co, IRAN Control: Single dose of two Telfast 120mg tablets of Sanofi

Plasma concentration of Hydrochlorothiazide at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. after dosing

Changing the drug dose from 180 mg tablet to 120 mg tablet

Using the rand command in Excel software, one of the sequences AB (test-reference product) or BA (reference-test product) is randomly assigned to each volunteer at random.