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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

NCT ID: NCT03885882

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-13

Study Completion Date

2019-06-26

Brief Summary

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

Detailed Description

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Conditions

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Healthy Subjects

Keywords

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E0302 Healthy Subjects E0302 SR Tablet E0302 IR Tablet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cohort 1 and Cohort 2 will receive treatment as parallel assignment. Cohort 3 will receive treatment in cross-over manner.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: E0302 Sustained Release (SR1) 1500 mcg

Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.

Group Type EXPERIMENTAL

E0302 SR1

Intervention Type DRUG

E0302 SR1, oral tablet.

Cohort 2: E0302 Sustained Release (SR3) 1500 mcg

Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.

Group Type EXPERIMENTAL

E0302 SR3

Intervention Type DRUG

E0302 SR3, oral tablet.

Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg

Participants will receive a single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 1 in Treatment Period 1 followed by single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.

Group Type EXPERIMENTAL

E0302 SR2

Intervention Type DRUG

E0302 SR2, oral tablet.

E0302 IR

Intervention Type DRUG

E0302 IR, oral tablet.

Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg

Participants will receive a single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 1 in Treatment Period 1 followed by single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.

Group Type EXPERIMENTAL

E0302 SR2

Intervention Type DRUG

E0302 SR2, oral tablet.

E0302 IR

Intervention Type DRUG

E0302 IR, oral tablet.

Interventions

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E0302 SR1

E0302 SR1, oral tablet.

Intervention Type DRUG

E0302 SR3

E0302 SR3, oral tablet.

Intervention Type DRUG

E0302 SR2

E0302 SR2, oral tablet.

Intervention Type DRUG

E0302 IR

E0302 IR, oral tablet.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Auckland Clinical Studies

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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E0302-J064-003

Identifier Type: -

Identifier Source: org_study_id