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Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
Indication Diabetic kidney disease
Efficacy
Primary
Secondary
Safety
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Group | Experimental |
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| B Group | Experimental |
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| C Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW1029M300mg | Drug | DW1029M300mg PO Once |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration of DW1029M in plasma | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under concentration-time curve of DW1029M in plasma | 24hours | |
| Time to maximal concentration of DW1029M in Plasma | 24hours | |
| Elimination half time of DW1029M in Plasma |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Cheol-hee Lim, CR Manager | DongWha Pharmaceutical Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju-si, Jeollabuk-do | Geonjiro, Deokjin-gu | 561-712 | South Korea |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| DW1029M600mg | Drug | DW1029M300mg 2 tablets Once |
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| DW1029M1200mg | Drug | DW1029M300mg 4 tablets PO Once |
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| 24hours |
| Apparent clearance of DW1029M in Plasma | 24hours |
| Apparent volume of distribution of DW1029M in Plasma | 24hours |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |