]>
IRCT20180620040164N23 IRCT 2022-04-03 ACtover Pharmaceutical Co. Bioequivalence study of Duloxetine 30 mg enteric coated capsule in 24 healthy male under fasting conditions Comparative bioequivalence study of Duloxetine 30 mg enteric coated capsule of ACTOVERCO and Eli Lilly Inc. in 24 healthy male under fasting conditions 2021-06-18 anticipated 26 Complete https://irct.ir/trial/59236 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule will be generated with the BEAR statistical software (Release V2.7.7). Each volunteer will be randomly assigned to one of the 2 different sequence of treatments according to the order of entering the study which will be allocated after screening. Bioequivalence Bioequivalence investigation of the generic Actover.Duloxetine 30 mg enteric coated capsule with brand Cymbalta® Eli Lilly capsule.. Intervention 1: Intervention group: Intervention group: (test): Duloxetine 30 mg enteric coated capsule, produced by Actover is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention 2: Intervention group: Intervention group: Duloxetine 30 mg enteric coated capsule, produced by Eli Lilly is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. No - There is not a plan to make this available Justification or reason for not sharing IPD is t's not specified yet.
public Ali Aghaei
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Noor Research & Development Institute scientific Seyed Mohsen Foroutan
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Tavan Institute Iran (Islamic Republic of) Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects who agree with patient consent form. 18 years 45 years Male Known hypersensitivity or idiosyncratic reaction to Duloxetine or inactive ingredients. History of sensitivity to heparin or heparin induced thrombocytopenia. Clinically significant infections within the past 3 months, evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent (>1 episode) or disseminated herpes zoster. Vaccination with live or attenuated vaccines within 6 weeks prior to dosing. History of narrow angle glaucoma. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Use of prescription or nonprescription drugs and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. History of regular alcohol or drug consumption within 6 months before screening Use of any medicinal product that is an inductor or strong inhibitor of CYP450 1A2 or 2D6 (eg, rifampicin, omeprazole, fluvoxamine, ciprofloxacin, fluoxetine, paroxetine, etc) within two weeks before administration of the investigational product and at any time during the study. Use of any medicinal product that inhibits monoamine oxidase A or B (eg, phenelzine, isocarboxacid, linezolid) within two weeks before administration of the investigational product and at any time during the study till at least 5 days after the last dose of investigational product. Consumption of grapefruit or grapefruit juice within 7 days prior to dosing. A history of difficulty with donating blood or donation of more than 450 ml blood within 60 days prior to the start of the study. Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product. Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: (test): Duloxetine 30 mg enteric coated capsule, produced by Actover is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention group: Intervention group: Duloxetine 30 mg enteric coated capsule, produced by Eli Lilly is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Peak Plasma Concentration (Cmax). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). ACtover Pharmaceutical Co. Approved 2020-02-03 Ethics committee of Shahid Beheshti University of Medical Sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)