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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong Wha Pharmaceutical Co. Ltd.

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