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

NCT02004327 | Completed Phase 1

• 1 other identifier: DW1029M-I-3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

• AUClast, AUCinf, AUClast/D, AUCinf/D
• Cmax, Cmax/D
• Secondary
• Tmax, t1/2, CL/F, Vz/F
• Safety
• Adverse Event Monitoring
• V/S, EKG, Laboratory Test, P/E

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Maximum Concentration of DW1029M in plasma

  24 hours

Secondary Outcomes (5)

• 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

  24hours

• Apparent clearance of DW1029M in Plasma

  24hours

• Apparent volume of distribution of DW1029M in Plasma

  24hours

Study Arms (3)

A Group

EXPERIMENTAL

1. 1st administration - DW1029M300mg PO Once 2. 2nd administration - DW1029M600mg PO Once 3. 3rd administration - DW1029M1200mg PO Once

Drug: DW1029M300mg; Drug: DW1029M600mg; Drug: DW1029M1200mg

B Group

EXPERIMENTAL

1. 1st administration - DW1029M600mg PO Once 2. 2nd administration - DW1029M1200mg PO Once 3. 3rd administration - DW1029M300mg PO Once

Drug: DW1029M300mg; Drug: DW1029M600mg; Drug: DW1029M1200mg

C Group

EXPERIMENTAL

1. 1st administration - DW1029M1200mg PO Once 2. 2nd administration - DW1029M300mg PO Once 3. 3rd administration - DW1029M600mg PO Once

Drug: DW1029M300mg; Drug: DW1029M600mg; Drug: DW1029M1200mg

Interventions

DW1029M300mg DRUG

DW1029M300mg PO Once

Also known as: DW1029M300mg 1 tablet

A Group; B Group; C Group

DW1029M600mg DRUG

DW1029M300mg 2 tablets Once

Also known as: DW1029M300mg 2 tablets

A Group; B Group; C Group

DW1029M1200mg DRUG

DW1029M300mg 4 tablets PO Once

Also known as: DW1029M300mg 4 tablets

A Group; B Group; C Group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong Wha Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, 561-712, South Korea

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Cheol-hee Lim, CR Manager

  DongWha Pharmaceutical Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

KR (1)