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IRCT20180620040164N51 IRCT 2023-10-21 Karen Pharma and Food Supplement Co. Comparative in vivo evaluation of 2 Hydrochlorothiazide 50 mg Tablet formulations. Comparative bioequivalence study of Hydrochlorothiazide 50 mg Tablet of Karen. and APO-HYDRO® of Apotex INC as reference in 24 healthy male under fasting. 2023-11-16 anticipated 24 Complete https://irct.ir/trial/73225 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer numbers (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer. Bioequivalence Essential (primary) hypertension. Intervention 1: Intervention group 1: Hydrochlorothiazide 50 mg Tablet , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 2 will be given to these subjects. Intervention 2: Intervention group 2: APO-HYDRO 50 mg tablet, produced by Apotex INC is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 1 will be given to these subjects. 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 It's undetermind yet.
public Ali Aghaei
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Noor Research & Development Institute scientific Seyed Mohsen Foroutan
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 mforoutan@gmail.com Tavan Institute Iran (Islamic Republic of) Healthy volunteers Between 18 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with normal vital signs. 18 years 45 years Male Subjects with a history of known hypersensitivity to hydrochlorothiazide or other sulfonamide drugs, associated acute or chronic infections; Volunteers who have water and electrolyte disorders, including low blood potassium and sodium, history of diarrhea or vomiting, headache, muscle cramps or weakness in the past two weeks; blood pressure in standing position and after at least 5 minutes of rest, systole less than 100 or more than 140 mmHg and diastole less than 60 or more than 90 mmHg); Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period; volunteers with a history of difficulty with donating blood; donation of more than 500 ml blood within 7 days prior to the start of the study; I10 Essential (primary) hypertension Treatment - Drugs Treatment - Drugs Intervention group 1: Hydrochlorothiazide 50 mg Tablet , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 2 will be given to these subjects. Intervention group 2: APO-HYDRO 50 mg tablet, produced by Apotex INC is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 1 will be given to these subjects. Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). Karen Pharma and Food Supplement Co. Approved 2023-10-09 Ethics Committee,School of Pharmacy,Nursing&Midwifery-Shahid Beheshti University of medical sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)