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IRCT20200105046010N53 IRCT 2022-01-23 Actero middle east Pharm. Co. In-vivo Bioequivalence Test of Linalidomide capsules with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK) In- Vivo Bioequivalence study of Linalidomide capsule 25 mg (Actero Pharma., Iran) with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb,UK) in Iranian healthy volunteers. 2021-12-01 anticipated 24 Complete https://irct.ir/trial/60256 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: For this purpose, A 24- persons group will be selected and divided to two 12-persons groups randomly. The names of all volunteers will be written on paper pieces and wrapped in aluminum foils. The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B, Blinding description: Information of the type of administered drugs will be kept hidden from volunteers. Test and Brand drugs are removed from their packaging by the executor and placed in similar cans. Volunteers will not be informed about receiving the brand or test drug. Bioequivalence Bio equivalence test. Intervention 1: Intervention group: One test capsule (Lenalidomide tablet 25 mg, Actro Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and concentrations of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector. The study is designed as cross-over, two 72-hours period with one week wash out time. The interfering factors in the study including: inter-subject variability of volunteers, type of drug and healthy condition of volunteers. Intervention 2: Control group: One Reference capsule (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of Lenalidomide in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. The study is designed as cross-over, two 72-hours period with one week wash out time. The interfering factors in the study including: inter-subject variability of volunteers, type of drug and healthy condition of volunteers. No - There is not a plan to make this available Justification or reason for not sharing IPD is All information and data of the study will remain secured based on the agreement established between researcher and drug producer.
public Javad Shokri
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences scientific Javad Shokri
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old 18 years 55 years Both Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug Treatment - Other Treatment - Other Intervention group: One test capsule (Lenalidomide tablet 25 mg, Actro Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and concentrations of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector. The study is designed as cross-over, two 72-hours period with one week wash out time. The interfering factors in the study including: inter-subject variability of volunteers, type of drug and healthy condition of volunteers. Control group: One Reference capsule (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of Lenalidomide in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. The study is designed as cross-over, two 72-hours period with one week wash out time. The interfering factors in the study including: inter-subject variability of volunteers, type of drug and healthy condition of volunteers. Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours after taking the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector. Actero middle east Pharm. Co. Approved 2021-11-15 Ethics Committee of Tabriz University of Medical Sciences Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St. Tabriz East Azarbaijan Iran (Islamic Republic of)