A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants

• Status: Completed
• Trial end date: 2019-06-26
• Target enrollment: 0
• Participant gender: All

Summary

To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Co., Ltd.

Criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

1. Body mass index (BMI) of 18 to 30 kilogram per meter square [kg/m2], inclusive at Screening

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline

2. Subjects who contravene the restrictions on concomitant medications, food and beverages

3. Currently enrolled in another clinical study or used any investigational drug or device within 3 months preceding informed consent