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
NCT03885882 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2019-12-24
Summary
To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
E0302 SR1
E0302 SR1, oral tablet.
- DRUG
-
E0302 SR3
E0302 SR3, oral tablet.
- DRUG
-
E0302 SR2
E0302 SR2, oral tablet.
- DRUG
-
E0302 IR
E0302 IR, oral tablet.
Sponsors & Collaborators
-
Eisai Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-13
- Primary Completion
- 2019-06-26
- Completion
- 2019-06-26
Countries
- New Zealand
Study Locations
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