NCT03005223

Brief Summary

A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2017

Typical duration for phase_1 healthy

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

December 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

December 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 time versus plasma concentration curve (AUC)

    0 ~ 24 hours

Study Arms (2)

Study effect of DWC20163 on DWC20155/DWC20156 PK

EXPERIMENTAL

To study effect of DWC20163 on DWC20155/DWC20156 PK

Drug: Co-administration of DWC20155/DWC20156Drug: DWC20163

Study effect of DWC20155/DWC20156 on DWC20163 PK

EXPERIMENTAL

To study effect of DWC20155/DWC20156 on DWC20163 PK

Drug: Co-administration of DWC20155/DWC20156Drug: DWC20163

Interventions

Co-administration of DWC20155/DWC20156DRUG
Study effect of DWC20155/DWC20156 on DWC20163 PKStudy effect of DWC20163 on DWC20155/DWC20156 PK
DWC20163DRUG
Study effect of DWC20155/DWC20156 on DWC20163 PKStudy effect of DWC20163 on DWC20155/DWC20156 PK

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
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 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

December 26, 2016

First Posted

December 29, 2016

Study Start

January 4, 2017

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

February 16, 2017

Record last verified: 2017-02