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IRCT20200625047913N4 IRCT 2021-02-02 Hezareh Sevom Futuristic Pharmacist Bioequivalence study of Tetrabenazine Tablet 25 mg manufactured by Hoogar Daru company (Bioequivalence Tetrabenazine Tablet ) BRT Bioequivalence study of Tetrabenazine Tablet 25 mg manufactured by Hoogar Daru company 2021-05-21 anticipated 24 Complete https://irct.ir/trial/54035 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Blinding description: Tetrabenazine drug manufactured by Hoogar Daru Company from Iran and by Lundbeck Inc of America will be prescribed to them orally in two doses with an interval of 7 days. For example, if in the first period of the drug administration, the volunteer received the drug manufactured by Hoogar Darura, in the next turn, the volunteer will receive the drug manufactured by Lundbeck Inc. No one knows which medication will be administrated in each week. Bioequivalence -. Intervention 1: Intervention group: Prescription of Tetrabenazine 25 mg tablets made by Hoogar Daru company from Iran in the first week. Intervention 2: Control group: Prescription of Tetrabenazine 25 mg tablets made by Lundbeck Inc from America in the Second week. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: from 2021 To whom: People working in industry and academia Conditions: Specify the exact purpose of the requested documentation 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/sending data 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 BMI: 18.5 to 24.9 weight in kg/(height in meter) 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 drug 18 years 45 years Both History of allergic responses to Tetrabenazine 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 use. 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 Intervention group: Prescription of Tetrabenazine 25 mg tablets made by Hoogar Daru company from Iran in the first week Control group: Prescription of Tetrabenazine 25 mg tablets made by Lundbeck Inc from America in the Second week Plasma concentration. Timepoint: 0.33, 0.67, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 9, 12, 24 hour. Method of measurement: LC Mass Mass. Hezareh Sevom Futuristic Pharmacist Approved 2021-01-26 Ethics committee of Tehran University of Medical Sciences First floor, Building number 1 of school of medicine, North Door of the University, Poursina St, Ghods St, Enghelab St, Tehran. Iran تهران Tehran Iran (Islamic Republic of)