Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

Daewoong Pharmaceutical

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: DWJ1458 (fasted); Drug: DWJ1458 (fed)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04393597

DW_DWJ1458102

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: DWJ1458 (fasted)

Drug: DWJ1458 (fed)

Group 2

Experimental group

Description:

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

Treatment:

Drug: DWJ1458 (fasted)

Drug: DWJ1458 (fed)