EUCTR2014-005448-17-GB进行中（未招募）1 期
A Phase 1, open-label, randomized, 2-panel, 3-way crossover study in healthy adult subjects to assess the relative bioavailability of simeprevir following single dose administration of age-appropriate oral formulation candidates, compared to the 150-mg oral capsule, and to assess the effect of food on the bioavailability of simeprevir following single dose administration of a selected age-appropriate oral formulation candidate.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Participants must be healthy on the basis of physical examination, medical history, 12-lead electrocardiogram (ECG) and vital signs performed at screening (after signing the ICF), and on Day -1
- •of the first treatment session, if applicable. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents
- •- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- •- Female participants, except for postmenopausal women, should have a negative serum pregnancy test at screening
- •- All female participants should have a negative urine pregnancy test on Day -1 of the first treatment session
- •- Male participants heterosexually active with a woman of childbearing potential must agree to use two effective methods of birth control and all men must not donate sperm during the study and for at least 30 days after receiving the last dose of study drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Female participants who are pregnant or breast feeding at screening or on Day -1 of the first treatment session
- •- Participants with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin [IgM]), or hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by HCV antibody), or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection
- •- Participants with a history or evidence of current or past abuse of alcohol, or recreational or narcotic drugs, which in the Investigator’s opinion would compromise the participant's safety and/or compliance with the study procedures
- •- Participants with any history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- •- Participants with known allergies, hypersensitivity, or intolerance to simeprevir (SMV) or any of the excipients
研究者
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