Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: DWJ1439; Drug: DWC202003; Drug: DWC202004; Drug: DWJ1464

Study type: Interventional

Funder types: Industry

Identifiers

NCT04477369

DW_DWJ1464101

Details and patient eligibility

About

The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.

Full description

The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study

Enrollment: 28 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteers aged 19 years old to under 55.
• BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
• Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
• Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
• 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

• Known history or presence of any clinically significant medical condition.
• Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
• Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
• Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
• Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Sequence A

Other group

Description:

7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.

Treatment:

Drug: DWJ1439

Drug: DWC202003

Drug: DWJ1464

Sequence B

Other group

Description:

7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.

Treatment:

Drug: DWC202004

Drug: DWC202003

Drug: DWJ1464

Sequence C

Other group

Description:

7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.

Treatment:

Drug: DWC202004

Drug: DWJ1439

Drug: DWC202003

Sequence D

Other group

Description:

7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.

Treatment:

Drug: DWC202004

Drug: DWJ1439

Drug: DWJ1464