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

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ClinicalTrials.gov Identifier: NCT02004327
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.

Tracking Information
First Submitted Date  ICMJE November 14, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date June 29, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
Maximum Concentration of DW1029M in plasma [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
- AUClast, AUCinf, AUClast/D, AUCinf/D - Cmax, Cmax/D [ Time Frame: 19~21d ]
Change History Complete list of historical versions of study NCT02004327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
  • Area under concentration-time curve of DW1029M in plasma [ Time Frame: 24hours ]
  • Time to maximal concentration of DW1029M in Plasma [ Time Frame: 24hours ]
  • Elimination half time of DW1029M in Plasma [ Time Frame: 24hours ]
  • Apparent clearance of DW1029M in Plasma [ Time Frame: 24hours ]
  • Apparent volume of distribution of DW1029M in Plasma [ Time Frame: 24hours ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
Official Title  ICMJE 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
Brief Summary
  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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetic Kidney Disease
Intervention  ICMJE
  • Drug: DW1029M300mg
    DW1029M300mg PO Once
    Other Name: DW1029M300mg 1 tablet
  • Drug: DW1029M600mg
    DW1029M300mg 2 tablets Once
    Other Name: DW1029M300mg 2 tablets
  • Drug: DW1029M1200mg
    DW1029M300mg 4 tablets PO Once
    Other Name: DW1029M300mg 4 tablets
Study Arms  ICMJE
  • Experimental: A Group
    1. 1st administration - DW1029M300mg PO Once
    2. 2nd administration - DW1029M600mg PO Once
    3. 3rd administration - DW1029M1200mg PO Once
    Interventions:
    • Drug: DW1029M300mg
    • Drug: DW1029M600mg
    • Drug: DW1029M1200mg
  • Experimental: B Group
    1. 1st administration - DW1029M600mg PO Once
    2. 2nd administration - DW1029M1200mg PO Once
    3. 3rd administration - DW1029M300mg PO Once
    Interventions:
    • Drug: DW1029M300mg
    • Drug: DW1029M600mg
    • Drug: DW1029M1200mg
  • Experimental: C Group
    1. 1st administration - DW1029M1200mg PO Once
    2. 2nd administration - DW1029M300mg PO Once
    3. 3rd administration - DW1029M600mg PO Once
    Interventions:
    • Drug: DW1029M300mg
    • Drug: DW1029M600mg
    • Drug: DW1029M1200mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2013)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004327
Other Study ID Numbers  ICMJE DW1029M-I-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong Wha Pharmaceutical Co. Ltd.
Study Sponsor  ICMJE Dong Wha Pharmaceutical Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cheol-hee Lim, CR Manager DongWha Pharmaceutical Company
PRS Account Dong Wha Pharmaceutical Co. Ltd.
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP