Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers

An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of DWJ1392 and DWC20164 in Healthy Male Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03016520

Enrollment

Registered

2017-01-10

Start date

2017-01-09

Completion date

2017-03-31

Last updated

2017-02-08

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

Conditions

Healthy

Brief summary

The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164 in healthy male volunteers.

Interventions

DRUGDWJ1392

DRUGDWC20164

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* No clinically significant findings * Age 19-50 years at screening

Exclusion criteria

* Who has allergy to investigational product

Design outcomes

Primary

Measure	Time frame
Maximum Plasma Concentration (Cmax)	0-72 hours
Area under the plasma concentration versus time curve (AUC)	0-72 hours

Countries

South Korea

Outcome results

None listed

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