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IRCT20200407046981N6 IRCT 2021-03-24 Kimia pharmaceutical Co Study of absorption and elimination rate of Gefitinib 250 mg tablets in comparison with standard tablet of Iressa® (AstraZeneca company). Randomized, single-dose, crossover comparative bioequivalence study of the Gefitinib 250 mg tablets produced by Kimia pharmaceutical Co versus Iressa® (AstraZeneca company) in 30 healthy males under fasting conditions 2020-05-04 anticipated 30 Complete https://irct.ir/trial/55035 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: Individuals will be recruited with advertising. 30 volunteers will be allocated to two sequences randomly by lottery method.The number was allocated according to their entrance to volunteers' list in screening day. Bioequivalence . Intervention 1: Intervention group (Test): Gefitinib 250 mg tablets, produced by Kimia pharmaceutical Co. is the test product. In each period, 15 of 30 subjects will be given single oral dose of this product. Intervention 2: Intervention group (Reference): Gefitinib 250 mg tablets (produced by AstraZeneca co.) is the reference product. In each period, 15 of 30 subjects will be given single oral dose of this product. 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 Undecided - It is not yet known if there will be a plan to make this available
public Hamed Hamishehkar
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 3336 7914 Hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Jaber Emami
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7111 Emami@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The weight limit for each volunteer is between 60 and 100 kg. All volunteers must be non-smokers. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. 18 years 60 years Male Known hypersensitivity or idiosyncratic reaction to Erlotinib or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing. Treatment - Drugs Treatment - Drugs Intervention group (Test): Gefitinib 250 mg tablets, produced by Kimia pharmaceutical Co. is the test product. In each period, 15 of 30 subjects will be given single oral dose of this product. Intervention group (Reference): Gefitinib 250 mg tablets (produced by AstraZeneca co.) is the reference product. In each period, 15 of 30 subjects will be given single oral dose of this product. Peak Plasma Concentration (Cmax), AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before intervention), 0.5، 1، 2، 3، 4، 5، 6، 8، 12، 24 ،48 ،72 ،96 and 120 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS) and using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSSIntervention groups. Kimia pharmaceutical Co Approved 2021-03-01 Ethics committee of Tabriz University of Medical Science Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)