Study to Explore Drug-drug Interactions Between DWC20155 and DWC20156 in Healthy Subjects

February 14, 2017 updated by: Daewoong Pharmaceutical Co. LTD.
A randomized, open-label, oral dose, crossover study to explore drug-drug interactions between DWC20155 and DWC20156 in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Accepts healthy volunteers.

Exclusion Criteria:

  • Who has allergy to investigational product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study effect of DWC20156 on DWC20155 PK
To study effect of DWC20156 on DWC20155 PK
Drug: DWC20156
Experimental: Study effect of DWC20155 on DWC20156 PK
To study effect of DWC20155 on DWC20156 PK
Drug: DWC20155

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: 0~24hr
0~24hr
Area under the plasma concentration versus time curve (AUC)
Time Frame: 0~24h
0~24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 27, 2016

First Submitted That Met QC Criteria

March 5, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DW_DWJ1366001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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