NCT03885882

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

An Open-Label, Randomized, Single Dose Study to Evaluate the Pharmacokinetics of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-04-13
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2019-03-22
• Last updated: 2019-12-24

Locations

1 site across 1 country: New Zealand