Bioequivalence investigation of the generic Actover.Duloxetine 30 mg enteric coated capsule with brand Cymbalta® Eli Lilly capsule..
Conditions
Interventions
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
Sponsors
ACtover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed