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

Diabetic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004327
• Other study ID #: DW1029M-I-3
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2013
• Last updated: June 25, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: Dong Wha Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• DW1029M300mg
DW1029M300mg PO Once
• DW1029M600mg
DW1029M300mg 2 tablets Once
• DW1029M1200mg
DW1029M300mg 4 tablets PO Once

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju-si, Jeollabuk-do	Geonjiro, Deokjin-gu

Sponsors (1)

Lead Sponsor	Collaborator
Dong Wha Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Concentration of DW1029M in plasma		24 hours	Yes
Secondary	Area under concentration-time curve of DW1029M in plasma		24hours	Yes
Secondary	Time to maximal concentration of DW1029M in Plasma		24hours	Yes
Secondary	Elimination half time of DW1029M in Plasma		24hours	Yes
Secondary	Apparent clearance of DW1029M in Plasma		24hours	Yes
Secondary	Apparent volume of distribution of DW1029M in Plasma		24hours	Yes