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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03885882

Enrollment

Registered

2019-03-22

Start date

2019-04-13

Completion date

2019-06-26

Last updated

2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

E0302, Healthy Subjects, E0302 SR Tablet, E0302 IR Tablet

Brief summary

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

Interventions

DRUGE0302 SR1

E0302 SR1, oral tablet.

DRUGE0302 SR3

E0302 SR3, oral tablet.

DRUGE0302 SR2

E0302 SR2, oral tablet.

DRUGE0302 IR

E0302 IR, oral tablet.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR	Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose
AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration	Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time	Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)	Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days
Number of Participants With Abnormal Clinical Laboratory Values	Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10
Number of Participants With Abnormal Vital Sign Values	Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
Number of Participants With Abnormal 12-lead Electrocardiogram Values	Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026