Clinical trial NCT02004327: The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Kidney Disease
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 6
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 .

Eligibility 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

Primary outcomes:
measure: Maximum Concentration of DW1029M in plasma
timeFrame: 24 hours
Secondary outcomes:
measure: Area under concentration-time curve of DW1029M in plasma
timeFrame: 24hours
measure: Time to maximal concentration of DW1029M in Plasma
timeFrame: 24hours
measure: Elimination half time of DW1029M in Plasma
timeFrame: 24hours
measure: Apparent clearance of DW1029M in Plasma
timeFrame: 24hours
measure: Apparent volume of distribution of DW1029M in Plasma
timeFrame: 24hours
Other outcomes:
Locations:
city: Jeonju-si, Jeollabuk-do
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Geonjiro, Deokjin-gu
Study officials:
affiliation: DongWha Pharmaceutical Company
name: Cheol-hee Lim, CR Manager
role: STUDY_DIRECTOR
References: