IRCT20230629058615N1已完成Unknown
Bioequivalence study of 100 mg doxycycline delayed-release capsules manufactured by Behshad Daroo company with reference product manufactured by Avet (Heritage)
Behshad Daroo Company0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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 40 years（—）
- 性别
- All
入选标准
- •Volunteer’s health (based on the results of physical examinations and clinical tests)
- •Volunteer’s health (based on the results of physical examinations and clinical tests)
- •Body mass index of 18.5-30 kg/m2
- •No history of allergy to tetracycline antibiotics and excipients used in the products formulations
- •No administration of potent cytochrome p450 inhibitors 4 weeks before start of the study
- •No history of diseases affecting the pharmacokinetic processes of the drug
- •No history of smoking, alcohol and narcotics use
- •Not being pregnant or breastfeeding
- •Adherence to study criteria based on ethical commitment and informed consent
- •Absence of severe liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)
排除标准
- •Tobacco or alcohol use, acute or chronic
- •Failure to obtain any of the mentioned items regarding health tests
- •Drug administration before and during the study
- •Lack of adherence to study criteria
- •Incidence of adverse reactions
- •liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)
研究者
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