Bioavailability of a New Oral Suspension of E3810

Phase 1

• Conditions: Bioavailability/Bioequivalence; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-001896-63-Outside-EU/EEA
• Lead Sponsor: Eisai Medical Research Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-27
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified