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IRCT20200625047913N5 IRCT 2021-02-21 Hezareh Sevom Futuristic Pharmacist Bioequivalence evaluation of Duloxetine Capsule 60 mg manufactured by Behin Tamin Rosamed company Bioequivalence evaluation of Duloxetine Capsule 60 mg manufactured by Behin Tamin Rosamed company 2021-03-02 anticipated 24 Complete https://irct.ir/trial/54031 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Blinding description: A test and reference drug will be administrated to the volunteers in first week and one week after that. Volunteers do not know which medication they are taking each week. Bioequivalence -. Intervention 1: Intervention group: Prescription of Duloxetine 60 mg capsule manufactured by Behin Tamin Rosamed company from Iran in the first week. Intervention 2: Control group: Prescription of Duloxetine 60 mg capsule manufactured by Eli lilly company from America in the first week. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: از سال 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/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 Body mass index: 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 Duloxetine 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 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 F33.0 Major depressive disorder, recurrent, mild Other Other Intervention group: Prescription of Duloxetine 60 mg capsule manufactured by Behin Tamin Rosamed company from Iran in the first week Control group: Prescription of Duloxetine 60 mg capsule manufactured by Eli lilly company from America in the first week Plasma concentration. Timepoint: 1، 2، 3، 4، 5/4، 5، 5/5، 6، 5/6، 7، 5/7، 8، 9، 10، 11، 12، 24، 36، 48، 72 hour. Method of measurement: LC MS MS. Hezareh Sevom Futuristic Pharmacist Approved 2021-01-26 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. تهران Tehran Iran (Islamic Republic of)