Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03016494

Enrollment

Registered

2017-01-10

Start date

2016-02-29

Completion date

Unknown

Last updated

2017-01-10

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 is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

Interventions

DRUGCo-administration of DWC20155 and DWC20156

DRUGDWJ1386 Tab.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI≥18.5 and ≤27.0 kg/m2 * No clinically significant findings * Age 19-55 years at screening

Exclusion criteria

* Who has allergy to investigational product

Design outcomes

Primary

Measure	Time frame
Maximum Plasma Concentration (Cmax)	0-24 hours
Area under the plasma concentration versus time curve (AUC)	0-24 hours

Countries

South Korea

Contacts

Primary ContactDaewoong Clinical

82-2-550-8106

Outcome results

None listed

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