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IRCT20130313012810N21 IRCT 2023-12-28 Tasnim pharmaceutical Company Study of absorption and elimination rate of Isotretinoin 20 mg, capsule in comparison with standard capsule of Isotretinoin brand (PoakkytaH ®). Comparative bioequivalence study of the Isotretinoin 20 mg, capsule manufactured by Tasnim Company 2024-01-04 anticipated 24 Complete https://irct.ir/trial/74630 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: To randomly assign people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope after entering the study, and numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of the both groups will change for the second period. Bioequivalence Bioequivalence study in healthy volunteers. Intervention group: This study examines the bioequivalence of the Isotretinoin capsule produced by a domestic company with a foreign brand sample. We have only one intervention group and there is no control group. The intervention group, which includes healthy, fasting volunteers, will receive a single dose, 20 mg tablet manufactured by the pharmaceutical company Tasnim and PoakkytaH® brand, in two 72-hour periods with an interval of one week, on the day of the study. And in 16 different time periods up to 72 hours after taking the medicine, blood samples will be taken from the volunteers in the amount of 3 ml each time, that is, a total of 48 ml within 72 hours. The training that will be given to the volunteers includes avoiding the consumption of drinks containing alcohol and xanthine and other interfering drugs in the prescription drug from 48 hours before the start of the study until the end of the study.. 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 Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3181 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3181 hamishehkar.hamed@gmail.com Tabriz 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 55 years Male History of allergic or adverse reaction to Isotretinoin or any similar product Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg Smokers Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s) N/A Intervention group: This study examines the bioequivalence of the Isotretinoin capsule produced by a domestic company with a foreign brand sample. We have only one intervention group and there is no control group. The intervention group, which includes healthy, fasting volunteers, will receive a single dose, 20 mg tablet manufactured by the pharmaceutical company Tasnim and PoakkytaH® brand, in two 72-hour periods with an interval of one week, on the day of the study. And in 16 different time periods up to 72 hours after taking the medicine, blood samples will be taken from the volunteers in the amount of 3 ml each time, that is, a total of 48 ml within 72 hours. The training that will be given to the volunteers includes avoiding the consumption of drinks containing alcohol and xanthine and other interfering drugs in the prescription drug from 48 hours before the start of the study until the end of the study. Plasma concentration of the drug. Timepoint: 16 sampling time included: -10, -2, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, and 72 h after taking the drug. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). Tasnim pharmaceutical Company Approved 2022-12-18 Ethics committee of Tabriz University of Medical Sciences Daneshghah St. Drug Applied Research Center Tabriz East Azarbaijan Iran (Islamic Republic of)