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IRCT20200407046981N4 IRCT 2020-12-02 Kimia pharmaceutical Co Study of absorption and elimination rate of Imatinib 100 mg capsules in comparison with standard tablet of Imatinib (Imatinib). Randomized, single-dose, crossover comparative bioequivalence study of the Imatinib 100 mg capsules produced by Kimia pharmaceutical Co versus Gleveec® (NOVARTIS company) in 18 healthy males under fasting conditions 2020-11-21 anticipated 18 Complete https://irct.ir/trial/52080 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Individuals are randomly selected with advertising. 18 volunteers categorized in two sequences randomly and the type of drug (Sample and Brand drug) will prescribe with lottery. Thus, if the first sequence of volunteers received Iranian medicine, they will receive brand medicine after the washout period. Bioequivalence In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Imatinib capsules of test and reference in healthy volunteers.. Intervention 1: Intervention group (Test): Imatinib 100 mg capsule, produced by Kimia pharmaceutical Co. is the test product. In each period, 9 of 18 subjects will be given single oral dose of this product. Intervention 2: Intervention group (Reference): Gleevec 100 mg capsules (produced by Novartis co.) is the reference product. In each period, 9 of 18 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. Only non-smokers are allowed to participate. They must be healthy in terms of liver and kidney status, respiratory system, and other general health characteristics that will be assessed. 18 years 60 years Male Known hypersensitivity or idiosyncratic reaction to Imatinib or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing. Treatment - Drugs Treatment - Drugs Intervention group (Test): Imatinib 100 mg capsule, produced by Kimia pharmaceutical Co. is the test product. In each period, 9 of 18 subjects will be given single oral dose of this product. Intervention group (Reference): Gleevec 100 mg capsules (produced by Novartis co.) is the reference product. In each period, 9 of 18 subjects will be given single oral dose of this product. Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 & 72 hour after dosing. Method of measurement: high-performance liquid chromatography—mass spectrometry (HPLC-MS). AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSSIntervention groups. Kimia pharmaceutical Co Approved 2020-08-02 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)