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Study aim
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A randomized, crossover bioequivalence study of single dose of test formulation (two tablets of Hydrochlorothiazide 25mg produced by ،Amin Pharm Co., IRAN) in comparison of reference product (two tablets of Esidrex 25mg of Juvice) by means of AUC0-t and Cmax in healthy adult human subjects under fasting conditions.
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Design
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A randomized, crossover bioequivalence study of single dose of test formulation (two tablets of Hydrochlorothiazide 25mg) produced by ،Amin Pharm Co., IRAN in comparison of reference product (two tablets of Esidrex 25mg) in 24 healthy adult human subjects under fasting conditions.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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;
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Intervention groups
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Intervention: Single dose of two Hydrochlorothiazide 25mg tablet of Amin Pharm Co., IRAN
Control: Single dose of two Esidrex 25mg tablets of Juvice
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Main outcome variables
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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