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IRCT20200513047423N4 IRCT 2021-11-28 Fatak Chemie Pars Bio equivalence study of Hydrochlorothiazide 50 mg tablets Bio equivalence study of Hydrochlorothiazide 50 mg tablets manufactured by Fatak Chemie Pars pharmaceutical company and comparing pharmacokinetics results with Hydrochlorothiazide tablets manufactured by Novartis in healthy volunteers 2021-12-03 anticipated 24 Complete https://irct.ir/trial/53909 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: One number from 1 to 24 will be allocated to each healthy volunteers. Then Extraction of 12 numbers (from 1 to 24) is carried out using https://kitset.ir/numbers/random#random-number-form. These first 12 random numbers create the first group, Blinding description: The main investigator divides 24 healthy volunteers in two groups, which each group includes twelve subjects. This process is performed using randomization method. In this study, just the main investigator is not blind. Test and reference drugs are packaged in special envelops that administrator and volunteers are all blinded regarding to the reference and test (generic) drug products. Bioequivalence Bioequivalance Hydrochlorothiazide 50 mg. Intervention 1: Intervention group: One Hydrochlorothiazide 50 mg tablet manufactured by Fatak Chime Pars company (Test drug) is administrated to each of 12 healthy volunteers of group 1. Washout period is one week. Intervention 2: Control group: 2 Hydrochlorothiazide 25 mg tablet manufactured by NOVARTIS company is administrated to each of 12 healthy volunteers of group 2. Yes - There is a plan to make this available What will be shared: Demography tables of volunteers including group 1 and 2 have been shared in bioequivalance report. Volunteer data include name, sex, BMI, height and weight. When: The results of bioequivalance study of Hydrochlorothiazide will be shared after accepting by Iranian food and drug organization . To whom: The results of bioequivalance study of Hydrochlorothiazide tablets will be accessed by expert by Iranian food and drug organization and financial supporter. Conditions: To promotion of result of investigation, the results will bi shared with eager. Where to obtain: 1- Iranian food and drug organization 2- Ofoqh pharmed research laboratory. How to obtain: After the completion of bio-equivalence study, Manufacturing company of generic product requests all data and document by a written letter. Generic manufacturer submits all these data to Drug Regulatory Administration to evaluate the results. Comments:
public Dr Amir Mehdizadeh
Apart 14, No.65, Razi Ave, Enghelab Ave
Tehran Iran (Islamic Republic of) 1133713144 +98 21 6673 8727 farzadkf@yahoo.com Ofoqh pharmed labratory scientific Dr Setareh Akbari
Unit 14, No. 65, Razi St, Enqelab Ave.
Tehran Iran (Islamic Republic of) 1133713144 +98 21 8862 2578 a_mehdizadeh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Healthy liver Healthy Kidney Observing BMI Age range between 18 and 50 years Male and female 18 years 50 years Both Smoking Pregnancy Behavior Behavior Intervention group: One Hydrochlorothiazide 50 mg tablet manufactured by Fatak Chime Pars company (Test drug) is administrated to each of 12 healthy volunteers of group 1. Washout period is one week. Control group: 2 Hydrochlorothiazide 25 mg tablet manufactured by NOVARTIS company is administrated to each of 12 healthy volunteers of group 2. Maximum Plasma Concentration (Cmax): after drug administration, gradually the plasma concentrations increase to Cmax. After Cmax, the plasma concentrations decrease regarding to drug elimination phenomena. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography. Tmax: the time after drug administration take to reach drug plasma concentration to Cmax. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography. Area under curve (AUC): AUC is obtained by plotting the plasma concentrations against corresponding times. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography. Fatak Chemie Pars Approved 2021-10-05 Ethics committee of Iran University of Medical Sciences No. 65, Razi Ave, Enghelab Ave Tehran Tehran Iran (Islamic Republic of)