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

NCT02004327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-06-29

No results posted yet for this study

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

Conditions

  • Diabetic Kidney Disease

Interventions

DRUG

DW1029M300mg

DW1029M300mg PO Once

DRUG

DW1029M600mg

DW1029M300mg 2 tablets Once

DRUG

DW1029M1200mg

DW1029M300mg 4 tablets PO Once

Sponsors & Collaborators

  • Dong Wha Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Cheol-hee Lim, CR Manager · DongWha Pharmaceutical Company

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004327 on ClinicalTrials.gov