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IRCT20130313012810N41 IRCT 2024-11-12 Iran hormone Exemestane tablet bioequivalence Bioequivalence study of the Exemestane 25 mg tablets manufactured Iran hormone pharmaceutical Co. 2024-11-10 anticipated 24 Complete https://irct.ir/trial/79877 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. Bioequivalence Bioequivalence study in healthy volunteers. Intervention 1: Intervention group 1, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 25 mg manufactured by Iran hormone Pharmaceutical Company. Intervention 2: Intervention group 2, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 25 mg manufactured by Pfizer Pharmaceutical Company. 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 Industry license will be required
public Mehrdad Hamidi
Zanjan University of Medical Sciences, Sobooti road, Zanjan, Zanjan Province
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3342 0651 hamidi@hidapharma.com Zanjan University of Medical Sciences scientific Mehrdad Hamidi
Zanjan University of Medical Sciences, Sobooti road, Zanjan, Zanjan Province,
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3342 0651 hamidi@hidapharma.com Zanjan University of Medical Sciences Iran (Islamic Republic of) The weight range of participating candidates should be between 60-100 kg Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (γ-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose. Volunteers who have agreed to an informed consent form. All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw 18 years 50 years Both History of allergic or adverse reaction to Exemestane or any similar product Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s) Smokers N/A N/A Intervention group 1, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 25 mg manufactured by Iran hormone Pharmaceutical Company. Intervention group 2, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 25 mg manufactured by Pfizer Pharmaceutical Company. Plasma concentration of the drug. Timepoint: 18 sampling time till 72 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). Iran hormone Approved 2024-10-14 Ethics committee of Tabriz University of Medical Sciences Daneshghah St. Drug Applied Research Center Tabriz East Azarbaijan Iran (Islamic Republic of)