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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.

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

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: DW1029M300mg Drug: DW1029M600mg Drug: DW1029M1200mg Phase 1

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 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : December 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 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

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 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

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 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




Primary Outcome Measures :
  1. Maximum Concentration of DW1029M in plasma [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Area under concentration-time curve of DW1029M in plasma [ Time Frame: 24hours ]
  2. Time to maximal concentration of DW1029M in Plasma [ Time Frame: 24hours ]
  3. Elimination half time of DW1029M in Plasma [ Time Frame: 24hours ]
  4. Apparent clearance of DW1029M in Plasma [ Time Frame: 24hours ]
  5. Apparent volume of distribution of DW1029M in Plasma [ Time Frame: 24hours ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004327


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, Korea, Republic of, 561-712
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
Investigators
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Study Director: Cheol-hee Lim, CR Manager DongWha Pharmaceutical Company

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Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT02004327     History of Changes
Other Study ID Numbers: DW1029M-I-3
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases