The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer

June 25, 2015 updated by: Dong Wha Pharmaceutical Co. Ltd.

Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer

  1. Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
  2. Indication Diabetic kidney disease

  3. Efficacy

    1. Primary

      • AUClast, AUCinf, AUClast/D, AUCinf/D
      • Cmax, Cmax/D

    2. Secondary

      • Tmax, t1/2, CL/F, Vz/F

  4. Safety

    1. Adverse Event Monitoring
    2. V/S, EKG, Laboratory Test, P/E

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.

Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .

The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .

One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .

The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .

Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second .

Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed.

After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .

Study Type

Interventional

Enrollment (Actual)

6

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

  • Korea, Republic of
    • Geonjiro, Deokjin-gu
      • Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, Korea, Republic of, 561-712
        • Chonbuk National University Hospital

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • More than 20 years of age at the time of screening and less than 55 years old healthy male

  • (17.5 ~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more

    ☞ body mass index (BMI) = weight (kg) / height (m) 2

  • No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings

Exclusion Criteria:

  • Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
  • Drugs that may affect the absorption of all the states (eg, gastrectomy)
  • Investigational drugs within two months before the first dose participated in other clinical trials

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: A Group
  1. 1st administration - DW1029M300mg PO Once
  2. 2nd administration - DW1029M600mg PO Once
  3. 3rd administration - DW1029M1200mg PO Once
Drug: DW1029M300mg
DW1029M300mg PO Once
Other Names:
  • DW1029M300mg 1 tablet
Drug: DW1029M600mg
DW1029M300mg 2 tablets Once
Other Names:
  • DW1029M300mg 2 tablets
Drug: DW1029M1200mg
DW1029M300mg 4 tablets PO Once
Other Names:
  • DW1029M300mg 4 tablets
Experimental: B Group
  1. 1st administration - DW1029M600mg PO Once
  2. 2nd administration - DW1029M1200mg PO Once
  3. 3rd administration - DW1029M300mg PO Once
Drug: DW1029M300mg
DW1029M300mg PO Once
Other Names:
  • DW1029M300mg 1 tablet
Drug: DW1029M600mg
DW1029M300mg 2 tablets Once
Other Names:
  • DW1029M300mg 2 tablets
Drug: DW1029M1200mg
DW1029M300mg 4 tablets PO Once
Other Names:
  • DW1029M300mg 4 tablets
Experimental: C Group
  1. 1st administration - DW1029M1200mg PO Once
  2. 2nd administration - DW1029M300mg PO Once
  3. 3rd administration - DW1029M600mg PO Once
Drug: DW1029M300mg
DW1029M300mg PO Once
Other Names:
  • DW1029M300mg 1 tablet
Drug: DW1029M600mg
DW1029M300mg 2 tablets Once
Other Names:
  • DW1029M300mg 2 tablets
Drug: DW1029M1200mg
DW1029M300mg 4 tablets PO Once
Other Names:
  • DW1029M300mg 4 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Concentration of DW1029M in plasma
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under concentration-time curve of DW1029M in plasma
Time Frame: 24hours
24hours
Time to maximal concentration of DW1029M in Plasma
Time Frame: 24hours
24hours
Elimination half time of DW1029M in Plasma
Time Frame: 24hours
24hours
Apparent clearance of DW1029M in Plasma
Time Frame: 24hours
24hours
Apparent volume of distribution of DW1029M in Plasma
Time Frame: 24hours
24hours

Collaborators and Investigators

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

Sponsor

Dong Wha Pharmaceutical Co. Ltd.

Investigators

  • Study Director: Cheol-hee Lim, CR Manager, DongWha Pharmaceutical Company

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, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW1029M-I-3

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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