NCT02947139

Brief Summary

A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 29, 2016

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2016

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

25 days

First QC Date

October 26, 2016

Last Update Submit

February 14, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    0~24 hours

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

    0~24 hours

Study Arms (2)

Study effect of DWC20161 on DWC20155/DWC20156 PK

EXPERIMENTAL

To study effect of DWC20161 on DWC20155/DWC20156 PK

Drug: Co-administration of DWC20155/DWC20156Drug: DWC20161

Study effect of DWC20155/DWC20156 on DWC20161 PK

EXPERIMENTAL

To study effect of DWC20155/DWC20156 on DWC20161 PK

Drug: Co-administration of DWC20155/DWC20156Drug: DWC20161

Interventions

Co-administration of DWC20155/DWC20156DRUG
Study effect of DWC20155/DWC20156 on DWC20161 PKStudy effect of DWC20161 on DWC20155/DWC20156 PK
DWC20161DRUG
Study effect of DWC20155/DWC20156 on DWC20161 PKStudy effect of DWC20161 on DWC20155/DWC20156 PK

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Accepts healthy volunteers

You may not qualify if:

  • Who has allergy to investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundang CHA Medical Center

Gyunggi, 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

October 27, 2016

Study Start

September 29, 2016

Primary Completion

October 24, 2016

Study Completion

November 2, 2016

Last Updated

February 16, 2017

Record last verified: 2017-02

Locations

KR(1)