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IRCT20210201050197N7 IRCT 2023-12-24 Shahid Beheshti University of Medical Sciences Bioequivalence of Miglustat capsule Study of bioequivalence of 100mg Miglustat capsule in healthy volunteers after single dose oral administration 2024-01-05 anticipated 24 Complete https://irct.ir/trial/74524 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece, Randomization description: In order to randomize in this study, simple and restricted random allocation rule will be used. This method represents a large block for the total sample size, meaning that the balance in the number of people assigned to each group will be achieved at the end. For this purpose, first, 24 candidates who meet the inclusion criteria will be selected. Then, 12 lotteries for the intervention group and 12 lotteries for the control group will be placed inside a lottery container. Then, randomly, each of these 24 individuals will take a lottery out of the container without replacement and deliver the lottery to the project officer and the allocation of the group to the individual will be determined (the person, physician and nurse responsible are not aware of the allocation of the group to the individual). In the second phase of the study, the person in the control group will be transferred to the intervention group and vice versa, Blinding description: Volunteers and study physician are not aware of what products they have received at any time. Since the drug is removed from its box and blister and give to the volunteers, they will not know the type of medicine. The new drug are similar to the reference drug in terms of color, smell, flavor and consistency and all the apparent properties so that participants do not know the type of drug. Bioequivalence . Intervention 1: Intervention group: In this group, 12 volunteers receive a 100 mg Miglustat capsule made by Pharan shimi Company. Up to 24 hours, blood samples will be taken from the volunteers and plasma concentration of the drug will be measured by liquid chromatography. Each time, 5 cc blood samples are taken from volunteers. Then these 12 volunteers will enter the control group after one week. Intervention 2: Control group: In this group, 12 volunteers receive 100mg Zavesca capsule made by ALMAC PHARMA-UK company. Up to 24 hours, blood samples will be taken from the volunteers and plasma concentration of the drug will be measured by liquid chromatography. Each time, 5 cc blood samples are taken from volunteers. Then these 12 volunteers will enter the intervention group after one week. 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 No more information
public Azadeh Haeri
No 2660, School of Pharmacy Nursing and Midwifery, Shahid Beheshti Medical University, Niayesh building, Valiasr Ave
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0212 a_haeri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Azadeh Haeri
No 2660, School of Pharmacy Nursing and Midwifery, Shahid Beheshti Medical University, Niayesh building, Valiasr Ave
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0212 a_haeri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Healthy volunteer Age_18-50 year 18 years 50 years Both History of liver, kidney and cardiovascular diseases that can affect drug clearance from body History of taking any medication in the last two weeks Creatinine above 2 Other Other Intervention group: In this group, 12 volunteers receive a 100 mg Miglustat capsule made by Pharan shimi Company. Up to 24 hours, blood samples will be taken from the volunteers and plasma concentration of the drug will be measured by liquid chromatography. Each time, 5 cc blood samples are taken from volunteers. Then these 12 volunteers will enter the control group after one week. Control group: In this group, 12 volunteers receive 100mg Zavesca capsule made by ALMAC PHARMA-UK company. Up to 24 hours, blood samples will be taken from the volunteers and plasma concentration of the drug will be measured by liquid chromatography. Each time, 5 cc blood samples are taken from volunteers. Then these 12 volunteers will enter the intervention group after one week. Maximum plasma concentration of the drug. Timepoint: Before intervention and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours after intervention. Method of measurement: liquid chromatography-mass (LC-MS) device. Shahid Beheshti University of Medical Sciences Approved 2023-11-13 School of Pharmacy Nursing and Midwifery, Shahid Beheshti Medical University No:2660, Faculty of Pharmacy, Shahid beheshti university of medical scineces, Nyayesh complex, Valiasr st. Tehran Tehran Iran (Islamic Republic of)