NCT02502721

Brief Summary

A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2015

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

June 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

July 12, 2015

Last Update Submit

August 24, 2015

Conditions

Healthy

Keywords

Male

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    0~72hr

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

    0~72h

Study Arms (2)

Part A

EXPERIMENTAL

To study effect of DWC20151 on DWC20152 PK

Drug: DWC20151

Part B

EXPERIMENTAL

To study effect of DWC20152 on DWC20151 PK

Drug: DWC20152

Interventions

DWC20151DRUG
Part A
DWC20152DRUG
Part B

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects (18\~55 years)

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 Officials

  • Jinah Jung

    Busan paik hospital

    PRINCIPAL INVESTIGATOR

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

July 12, 2015

First Posted

July 20, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

KR(1)