Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

February 14, 2017 updated by: Daewoong Pharmaceutical Co. LTD.

A Randomized, Open Label, Crossover Study to Explore Drug-drug Interaction Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

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 45 years (Adult)

Accepts Healthy Volunteers

No

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 DWC20161 on DWC20155/DWC20156 PK
To study effect of DWC20161 on DWC20155/DWC20156 PK
Drug: Co-administration of DWC20155/DWC20156
Drug: DWC20161
Experimental: Study effect of DWC20155/DWC20156 on DWC20161 PK
To study effect of DWC20155/DWC20156 on DWC20161 PK
Drug: Co-administration of DWC20155/DWC20156
Drug: DWC20161

What is the study measuring?

Primary Outcome Measures

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

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 (Actual)

September 29, 2016

Primary Completion (Actual)

October 24, 2016

Study Completion (Actual)

November 2, 2016

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 27, 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_DWJ1366003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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Locations

3
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