Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-28

Study Completion Date

2020-11-30

Brief Summary

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The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.

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Detailed Description

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The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.

Group Type EXPERIMENTAL

DWJ1458 (fasted)

Intervention Type DRUG

Subjects take single dose of DWJ1458 on a fated condition

DWJ1458 (fed)

Intervention Type DRUG

Subjects take single dose of DWJ1458 after high-fat diet

Group 2

Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.

Group Type EXPERIMENTAL

DWJ1458 (fasted)

Intervention Type DRUG

Subjects take single dose of DWJ1458 on a fated condition

DWJ1458 (fed)

Intervention Type DRUG

Subjects take single dose of DWJ1458 after high-fat diet

Interventions

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DWJ1458 (fasted)

Subjects take single dose of DWJ1458 on a fated condition

Intervention Type DRUG

DWJ1458 (fed)

Subjects take single dose of DWJ1458 after high-fat diet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19 to 55 years
* BMI 18.5≥ and ≤27.0 kg/m²
* Female subjects must be menopause or surgically infertility.
* Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria

* History of hypersensitivity to investigational product
* Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
* The subject who is judged to be unsuitable as a test subject in a screening test.
* The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes