NCT00961025

A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects

A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.

Conditions

• Diabetes Mellitis Type 2

Interventions

Type	Name	Description
DRUG	DA-1229	single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg multiple dose study : DA-1229 5,10,20,40mg
DRUG	Placebo	placebo

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2009-08-18
• Last updated: 2009-08-24

Locations

1 site across 1 country: South Korea