NCT03016520

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

January 9, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 9, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

January 1, 2017

Enrollment Period

17 days

First QC Date

January 9, 2017

Last Update Submit

February 6, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration (Cmax)

    0-72 hours

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

    0-72 hours

Study Arms (2)

Test drug

EXPERIMENTAL

DWJ1392

Drug: DWJ1392

Reference drug

EXPERIMENTAL

DWC20164

Drug: DWC20164

Interventions

DWJ1392DRUG
Test drug
DWC20164DRUG
Reference drug

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant findings
  • Age 19-50 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)

Seoul ST. Mary's Hospital

Seoul, South Korea

RECRUITING

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

January 9, 2017

Primary Completion

January 26, 2017

Study Completion

March 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-01

Locations

KR(1)