A study to compare the relative bioavailability of SMTD and Gilead formulations of ledipasvir/sofosbuvir 90/400 mg tablets in 24 healthy adult male volunteers under fasting conditions

Sobhan Medicine Trade Development Company0 个研究点目标入组 24 人开始时间: 待定最近更新: 2018年2月22日

试验速览

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•1. Males, 18-50 years of age (inclusive). 2. The subject is able and willing to provide written informed consent. 3. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. 4. The subject has stable residence and telephone. 5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Exclusion criteria: 1. History of allergy or sensitivity to ledipasvir/sofosbuvir, or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 2. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 3. Presence of gastrointestinal disease or history of malabsorption within the last year. 4. Presence of a medical condition requiring regular treatment with prescription drugs. 5. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. 6. Receipt of any drug as part of a research study within 30 days prior to dosing. 7. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing.

发起方

Sobhan Medicine Trade Development Company