A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152

August 24, 2015 updated by: Daewoong Pharmaceutical Co. LTD.

A Randomized, Open-labeled, Oral Dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152 in Healthy Male Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).

Study Type

Interventional

Enrollment (Anticipated)

58

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects (18~55 years)

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: Part A
To study effect of DWC20151 on DWC20152 PK
Drug: DWC20151
Experimental: Part B
To study effect of DWC20152 on DWC20151 PK
Drug: DWC20152

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: 0~72hr
0~72hr
Area under the plasma concentration versus time curve (AUC)
Time Frame: 0~72h
0~72h

Collaborators and Investigators

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

Sponsor

Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: Jinah Jung, Busan Paik Hospital

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

June 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 12, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DWJ1373001

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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