NCT02952547

Brief Summary

The purpose of this study to Compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

27 days

First QC Date

October 26, 2016

Last Update Submit

February 14, 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

DWJ1366 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.

Drug: Co-administration of DWC20155 and DWC20156Drug: DWJ1366 Tab.

Reference / Test Drug

EXPERIMENTAL

Co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1366 Tab.

Drug: Co-administration of DWC20155 and DWC20156Drug: DWJ1366 Tab.

Interventions

Co-administration of DWC20155 and DWC20156DRUG
Reference / Test DrugTest / Reference Drug
DWJ1366 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, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 2, 2016

Study Start

October 30, 2016

Primary Completion

November 26, 2016

Study Completion

January 10, 2017

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)