]>
IRCT20210201050197N1 IRCT 2021-02-19 َArya Pharmaceutical Company Bioequivalence of Duloxetine Single-dose bioequivalence studies of Duloxetine (60 mg) in healthy volunteers 2021-02-26 anticipated 26 Complete https://irct.ir/trial/54297 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: In order to randomize, in this study, a random allocation rule has been used. For this purpose, first, a total sample size of volunteers who met the inclusion criteria was determined. In this way, 26 people who had passed the entry and exit criteria were selected and then assigned to each number by Excel program, and randomly 13 for the control group and 13 for the experimental group were selected. Then, by matching the number of people with their names, the two groups will be identified. Then, in the second period, the group that received the test drug received the reference drug and the other group received the test drug, Blinding description: Candidates receive medication twice. Once Iranian product (generic) and once the foreign product (reference). Volunteers and study physicians are not aware of what products they have received at every turn. Because the medicine is taken out of its box and blister and given to the volunteers, they will have no knowledge of the type of medicine. The new drug is made in terms of color, smell, taste, consistency, and all appearance characteristics similar to the reference drug so that the participants are blind in this regard. Bioequivalence Healthy subjects. Intervention 1: Intervention group: Receiving Iranian medicine (generic product): In this group, each volunteer receives a 60 mg Duloxetine tablets made by Aria Company during a treatment period. After that, blood samples are taken from the volunteers for 24 hours. Blood samples (5 cc) are taken from volunteers at different times (14 times). This completes a course of study. Pharmacokinetic parameters are calculated and compared by determining the drug concentration in blood samples by High-performance liquid chromatography (HPLC). Intervention 2: Control group: Control group: Receiving reference medicine: In this group, each volunteer receives one reference tablet of 60 mg Duloxetine in a course of treatment. After that, blood samples are taken from the volunteers for 24 hours. Blood samples (5 cc) are taken from volunteers at different times (14 times). This completes a course of study. Pharmacokinetic parameters are calculated and compared by determining the drug concentration in blood samples by High-performance liquid chromatography (HPLC). 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 Treatment - Drugs Treatment - Drugs Intervention group: Receiving Iranian medicine (generic product): In this group, each volunteer receives a 60 mg Duloxetine tablets made by Aria Company during a treatment period. After that, blood samples are taken from the volunteers for 24 hours. Blood samples (5 cc) are taken from volunteers at different times (14 times). This completes a course of study. Pharmacokinetic parameters are calculated and compared by determining the drug concentration in blood samples by High-performance liquid chromatography (HPLC). Control group: Control group: Receiving reference medicine: In this group, each volunteer receives one reference tablet of 60 mg Duloxetine in a course of treatment. After that, blood samples are taken from the volunteers for 24 hours. Blood samples (5 cc) are taken from volunteers at different times (14 times). This completes a course of study. Pharmacokinetic parameters are calculated and compared by determining the drug concentration in blood samples by High-performance liquid chromatography (HPLC). Plasma drug concentration. Timepoint: 1، 2، 3، 4، 5, 5.5, 6، 6.5, 7, 8، 10، 12، 24، 32, 48 hours. Method of measurement: High performance liquid chromatography (HPLC) method. َArya Pharmaceutical Company Approved 2021-02-14 School of Pharmacy Nursing and Midwifery, Shahid Beheshti Medical University No 2660, School of Pharmacy Nursing and Midwifery, Shahid Beheshti Medical University, Niayesh building, Valiasr Ave Tehran Tehran Iran (Islamic Republic of)