Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

January 9, 2017 updated by: Daewoong Pharmaceutical Co. LTD.

A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

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 Contact

  • Name: Daewoong Clinical
  • Phone Number: 82-2-550-8106

Study Locations

  • Korea, Republic of
    • Busanjin-gu
      • Busan, Busanjin-gu, Korea, Republic of, 614-735
        • Recruiting
        • Busan Paik Hospital
        • Contact:
          • Jae-Gook Shin, Professor
          • Phone Number: 82-51-890-6709

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:

  • BMI≥18.5 and ≤27.0 kg/m2
  • No clinically significant findings
  • Age 19-55 years at screening

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test/Reference Drug
DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
Drug: Co-administration of DWC20155 and DWC20156
Drug: DWJ1386 Tab.
Experimental: Reference/Test Drug
co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.
Drug: Co-administration of DWC20155 and DWC20156
Drug: DWJ1386 Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum 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

February 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DW_DWJ1386001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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