An Ascending Bioavailability of a New Oral Suspension of E3810

Eisai Medical Research Inc.0 个研究点目标入组 16 人开始时间: 2016年6月27日最近更新: 2016年7月4日

试验速览

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•1. Healthy males and non-pregnant females, 19 to 45 years old with a body mass index (BMI) of 18 to 30 kg/m2 inclusive (BMI =weight (kg)/[height (m)]2).
•2. Females had to be of child-bearing potential and practicing a medically acceptable method of mechanical contraception during screening and throughout the study. Postmenopausal women had to be amenorrheic for at least 12 months or have a follicle stimulating hormone (FSH) level of =40 IU/L.
•3. Subjects had to be willing and able to participate in the whole study and to provide written informed consent.
•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 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Evidence of significant hepatic, gastrointestinal (GI), renal, respiratory, endocrine, hematologic, neurologic, infectious, psychiatric, or cardiovascular system abnormalities.
•2. Known or suspected history of alcohol or drug misuse and/or positive urine drug screen for a prohibited agent.
•3. A positive test result for hepatitis B surface antigen (HBsAg), hepatitis C, or human immunodeficiency virus (HIV) screen.
•4. History of allergy or hypersensitive reactions to rabeprazole sodium, substituted benzimidazoles, or any component of the vehicle.
•5. History of a known genetic disorder in the enzyme that metabolizes phenylalanine (phenylketonurics ).
•6. Pregnant or breast-feeding women.
•Note: the list is not exhaustive.

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