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IRCT20200625047913N7 IRCT 2021-09-07 Hezareh Sevom Futuristic Pharmacist Bioequivalence evaluation of Aripiperazole 5 mg manufactured by Actover company BEA Bioequivalence evaluation of Aripiperazole 5 mg manufactured by Actover company 2021-08-31 anticipated 24 Complete https://irct.ir/trial/58152 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Blinding description: Regarding the study of the bioequivalence of aripiprazole, the participating volunteers do not know the type of medication they were receiving at each time. Candidates are given one dose of the test drug and then the reference drug will given them 42 days later. Candidates are not aware of which drug they are taking each time. The main researcher of the project, the doctor and the nurse are knowing about the type of medicine that the volunteer takes at each time. Bioequivalence SCHIZOPHRENIA. Intervention 1: Aripiperazole 5 mg Tablet manufactured by Actoverco pharmaceutical company from Iran will administrate in the first week. Intervention 2: Control group: Prescription of Aripiperazole 5 mg manufactured by Otsuka company from America in the first day of study. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts from March 1400 To whom: People working in industry and academia Conditions: People working in industry and academia Where to obtain: Sending email to info@hezareh-co.com - Sending fax to 00982188208678 - Calling to 00982188652343 - Responsible person: Tayebeh Ghari How to obtain: Sending email to info@hezareh-co.com Request evaluation during 1 week Sending data during 1 week Comments:
public Faranak Salmannejad
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora Blv,Karaj.
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 salmannejad.f@gmail.com Alborze University of Medical Sciencesو School of Pharmacy scientific Faranak Salmannejad
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora Blv,Karaj.
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 salmannejad.f@gmail.com Alborze University of Medical Sciencesو School of Pharmacy Iran (Islamic Republic of) 18 to 45 years old Sex: Males and/or non-pregnant, non-lactating females Body mass index: 18.5 to 24.9 weight in kg/(height in meter)g Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent A physical examination with no clinically significant finding and laboratory normal tests Do not take any chronic or acute medication for at least 1 week before the start of the study No history of diseases affecting the pharmacokinetic processes of the dru 18 years 45 years Both History of allergic responses to Aripiperazole or other related drugs, or any of its formulation ingredients Have significant diseases (which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system) or clinically significant abnormal findings during screening Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period History or evidence of drug dependence or of alcoholism or of moderate alcohol useو History of difficulty with donating blood or difficulty in accessibility of veins Volunteers who have received a known investigational drug within five elimination half life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater Found positive in urine test for drugs of abuse done before check-in of period History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption Other Other Aripiperazole 5 mg Tablet manufactured by Actoverco pharmaceutical company from Iran will administrate in the first week. Control group: Prescription of Aripiperazole 5 mg manufactured by Otsuka company from America in the first day of study Maximum plasma concentration. Timepoint: 0، 5/0، 1، 5/1، 2، 5/2، 3، 4، 5، 6، 7، 8، 10، 12، 24، 32، 48، 72 Hour. Method of measurement: Liquid chromatography mass mass (lc ms ms). Area under the curve. Timepoint: 0، 5/0، 1، 5/1، 2، 5/2، 3، 4، 5، 6، 7، 8، 10، 12، 24، 32، 48، 72 hr. Method of measurement: Liquid chromatography mass mass (lc ms ms). Time take to reach maximum plasma concentration. Timepoint: 0، 5/0، 1، 5/1، 2، 5/2، 3، 4، 5، 6، 7، 8، 10، 12، 24، 32، 48، 72 hr. Method of measurement: Clock. Hezareh Sevom Futuristic Pharmacist Approved 2021-08-16 Ethics committee of institute of pharmaceutical science of Tehran University of Medical Sciences 16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219, Tehran- Iran. Tehran Tehran Iran (Islamic Republic of)