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IRCT20190706044111N25 IRCT 2022-01-01 Jaber Ebne Hayyan Pharm. Co.. Bioequivalence study of Fexofenadine 120mg tablet of Jaber Ebne Hayyan Pharm. Co., IRAN 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 2022-01-21 anticipated 48 Complete https://irct.ir/trial/60799 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: 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. Bioequivalence allergic rhinitis. Intervention 1: Intervention group: two 120mg Fexofenadine tablets, produced by Jaber Ebne Hayyan Pharm. Co. (IRAN), single dose. Intervention 2: Control group: Telfast, two 120mg tablets, produced by Sanofi company, single dose. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Any publication is under permission of Jaber Ebne Hayyan Pharm. Co..
public Ladan Tayebi
1st floor, Saeidi Dd end, Felestin Ave.
Tehran Iran (Islamic Republic of) 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. scientific Ladan Tayebi
1st floor, Saeidi Dd end, Felestin Ave.
Tehran Iran (Islamic Republic of) 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. Iran (Islamic Republic of) - Aged between 18 - 50 years - Body weight between 50 – 100 kg - Having good health on the basis of medical history and physical & clinical examination - Understand the procedures and give written informed consent 18 years 50 years Both Subject had undergone surgery of the gastro-intestinal tract treatment. Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment. Z88.9 Allergy status to unspecified drug/meds/biol subst Other Other Intervention group: two 120mg Fexofenadine tablets, produced by Jaber Ebne Hayyan Pharm. Co. (IRAN), single dose. Control group: Telfast, two 120mg tablets, produced by Sanofi company, single dose. Plasma concentration of fexofenadine. Timepoint: 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. Method of measurement: High Performance Liquid Chromatography (HPLC). Jaber Ebne Hayyan Pharm. Co.. Approved 2021-12-12 Ethics committee of Zahedan University of medical Sciences Dr. Hessabi square Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)