NCT03016494

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 9, 2017

Last Update Submit

January 9, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration (Cmax)

    0-24 hours

  • Area under the plasma concentration versus time curve (AUC)

    0-24 hours

Study Arms (2)

Test/Reference Drug

EXPERIMENTAL

DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.

Drug: Co-administration of DWC20155 and DWC20156Drug: DWJ1386 Tab.

Reference/Test Drug

EXPERIMENTAL

co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.

Drug: Co-administration of DWC20155 and DWC20156Drug: DWJ1386 Tab.

Interventions

Co-administration of DWC20155 and DWC20156DRUG
Reference/Test DrugTest/Reference Drug
DWJ1386 Tab.DRUG
Reference/Test DrugTest/Reference Drug

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Who has allergy to investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Busan Paik Hospital

Busan, Busanjin-gu, 614-735, South Korea

RECRUITING

Central Study Contacts

Daewoong Clinical

CONTACT

82-2-550-8106

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 10, 2017

Study Start

February 1, 2016

Primary Completion

March 1, 2017

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)