]>
IRCT20200623047902N1 IRCT 2020-06-26 Zistdaru danesh Co. Bioequivalence study of Dimethyl fumarate capsule manufactured by Zistdaru danesh company (Teczifuma 240mg) in Iranian healthy volunteers Bioequivalence study and evaluation of pharmacokinetic parameters of Dimethyl fumarate medicine manufactured by Zistdaru danesh company (Teczifuma 240) versus Tecfidera 240 manufactured by Biogen Company (originator brand) in healthy volunteers 2020-06-30 anticipated 24 Complete https://irct.ir/trial/49151 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: People in different age groups are invited to collaborate through the advertisement. Then people are selected and individuals in each group randomly selected from the qualified people to participate in the project. The first twelve are considered as (first sequence: Teczifuma recipient) and the second twelve are considered as (second sequence:Tecfidera recipient), Blinding description: This study is a blind side clinical trial (volunteers). Tecfidera and Teczifuma are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form. Bioequivalence In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Dimethyl Fumarate capsule of test and reference in healthy volunteers.. Intervention 1: Intervention Group 1: Volunteers take Teczifuma capsule drug, which is manufactured by Zistdaru danesh Company and contains 240 mg of dimethyl fumarate,as a test product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the active form of the drug in the blood is determined. Intervention 2: Intervention Group 2: Volunteers take Tecfidera capsule drug, which is manufactured by Biogen Company and contains 240 mg of dimethyl fumarate, as a reference product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the active form of the drug in the blood is determined. Yes - There is a plan to make this available What will be shared: blood concentration data When: 8 months after publication of results To whom: University researchers Conditions: Do similar studies Where to obtain: Elham Ghasemian Ghasemian@zistdaru.ir How to obtain: After evaluation of reasons to apply, it will be sent during 60 working days Comments:
public Elham Ghasemian
Zistdaru danesh Co., second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St
Tehran Iran (Islamic Republic of) 1417833714 +98 21 6696 5196 ghasemian@zistdaru.ir Zistdaru danesh Co. scientific Elham Ghasemian
Zistdaru danesh Co., second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St
Tehran Iran (Islamic Republic of) 1417833714 +98 21 6696 5196 ghasemian@zistdaru.ir Zistdaru danesh Co Iran (Islamic Republic of) General Health (Liver, Heart and Kidney), Body Mass Index (18-28), Conscious Consciousness, Age (18-60) 18 years 60 years Both Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction, history of drug allergy Treatment - Drugs Treatment - Drugs Intervention Group 1: Volunteers take Teczifuma capsule drug, which is manufactured by Zistdaru danesh Company and contains 240 mg of dimethyl fumarate,as a test product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the active form of the drug in the blood is determined. Intervention Group 2: Volunteers take Tecfidera capsule drug, which is manufactured by Biogen Company and contains 240 mg of dimethyl fumarate, as a reference product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the active form of the drug in the blood is determined. Determination of concentration of active form of drug in bood. Timepoint: After taking blood sample. Method of measurement: HPLC-MASS MASS. Zistdaru danesh Co. Approved 2019-04-24 Ethics committee of Islamic Azad University-Damghan Branch Zistdaru danesh Co., Second floor, No.98, Bozorgmehr St., Velsale Shirazi st., Enghelan St. Tehran Tehran Iran (Islamic Republic of)