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IRCT20210201050197N3 IRCT 2021-03-08 َArya Pharmaceutical Company Bioequivalence of Gemifloxacin Single-dose bioequivalence studies of Gemifloxacin tablets (320 mg) in healthy volunteers 2021-02-04 anticipated 26 Complete https://irct.ir/trial/54042 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: In order to allocate randomly in this study, the simple and limited random allocation rule will be used. This method represents a large block for the total sample size, which means that the balance in the number of people assigned to each group will be achieved at the end. For this purpose, 26 candidates who meet the inclusion criteria will be selected first. Then, 13 lots for the intervention group and 13 lots for the control group are placed in a lottery container. Then, each of these 26 people randomly removes a lottery ticket from the container without replacement and deliver the lottery to the person in charge of the project and the group allocation to the individual is determined (the individual, the doctor, and the responsible nurse are not aware of the group allocation to the individual). In the second phase of the study, the individual in the control group is transferred to the intervention group and vice versa, 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 320 mg gemifloxacin 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: Receiving reference medicine: In this group, each volunteer receives one reference tablet of 320 mg Gemifloxacin 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 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 Male 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 320 mg gemifloxacin 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: Receiving reference medicine: In this group, each volunteer receives one reference tablet of 320 mg Gemifloxacin 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 HPLC. Plasma drug concentration. Timepoint: 20, 40 Mins, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24 Hours. Method of measurement: High performance liquid chromatography (HPLC) method. َArya Pharmaceutical Company Approved 2020-05-31 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)