IRCT20180620040164N23已完成未知
Comparative bioequivalence study of Duloxetine 30 mg enteric coated capsule of ACTOVERCO and Eli Lilly Inc. in 24 healthy male under fasting conditions
ACtover Pharmaceutical Co.0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 45 years（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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.
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