Pharmacokinetics and Safety Between DWJ1421 and DWC201903 in Healthy Male Volunteers

A Randomized, Open Label, Single Dose, Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1421 and DWC201903 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04278391

Enrollment

Registered

2020-02-20

Start date

2019-07-02

Completion date

2020-02-19

Last updated

2020-02-20

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

Conditions

Healthy

Brief summary

This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between DWJ1421 and DWC201903 in healthy male volunteers.

Interventions

DRUGDWJ1421

1 tablet administered in fasting condition

DRUGDWC201903

1 tablet administered in fasting condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Between 19 aged and 45 aged in healthy male adult * Body weight more than 50kg * Body Mass Index more than 18.0 and under 27.0

Exclusion criteria

* Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history * Those who have a gastrointestinal disease history that can effect drug absorption or surgery * Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product

Design outcomes

Primary

Measure	Time frame	Description
Cmax	0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h	Maximum concentration of DWJ1421
AUClast	0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h	Area under the drug concentration-time curve

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026