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

NCT ID: NCT02004327

Last Updated: 2015-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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 .

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A Group

1. 1st administration - DW1029M300mg PO Once

2. 2nd administration - DW1029M600mg PO Once

3. 3rd administration - DW1029M1200mg PO Once

Group Type: EXPERIMENTAL

DW1029M300mg

Intervention Type: DRUG

DW1029M300mg PO Once

DW1029M600mg

Intervention Type: DRUG

DW1029M300mg 2 tablets Once

DW1029M1200mg

Intervention Type: DRUG

DW1029M300mg 4 tablets PO Once

B Group

1. 1st administration - DW1029M600mg PO Once

2. 2nd administration - DW1029M1200mg PO Once

3. 3rd administration - DW1029M300mg PO Once

Group Type: EXPERIMENTAL

DW1029M300mg

Intervention Type: DRUG

DW1029M300mg PO Once

DW1029M600mg

Intervention Type: DRUG

DW1029M300mg 2 tablets Once

DW1029M1200mg

Intervention Type: DRUG

DW1029M300mg 4 tablets PO Once

C Group

1. 1st administration - DW1029M1200mg PO Once

2. 2nd administration - DW1029M300mg PO Once

3. 3rd administration - DW1029M600mg PO Once

Group Type: EXPERIMENTAL

DW1029M300mg

Intervention Type: DRUG

DW1029M300mg PO Once

DW1029M600mg

Intervention Type: DRUG

DW1029M300mg 2 tablets Once

DW1029M1200mg

Intervention Type: DRUG

DW1029M300mg 4 tablets PO Once

Interventions

DW1029M300mg

DW1029M300mg PO Once

Intervention Type: DRUG

DW1029M600mg

DW1029M300mg 2 tablets Once

Intervention Type: DRUG

DW1029M1200mg

DW1029M300mg 4 tablets PO Once

Intervention Type: DRUG

Other Intervention Names

DW1029M300mg 1 tablet; DW1029M300mg 2 tablets; DW1029M300mg 4 tablets

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dong Wha Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheol-hee Lim, CR Manager

Role: STUDY_DIRECTOR

DongWha Pharmaceutical Company

Locations

Chonbuk National University Hospital

Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, South Korea

Countries

South Korea

Other Identifiers

DW1029M-I-3

Identifier Type: -

Identifier Source: org_study_id