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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitis Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

DA-1229

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg

multiple dose study : DA-1229 5,10,20,40mg

Interventions

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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

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20-45 years healthy male subjects
* Body weight :50-90kg, BMI between 18.5-25
* Blood glucose level of 70-110mg/dL on the FPG test

Exclusion Criteria

* have a family history of diabetes
* Serum AST(SGOT), ALT(SGPT)\>1.25 times upper limit of normal
* Creatinine clearance rate\<80mL/min
* show SBP =\<100mmHg or \>=150mmHg, or DBP=\<65mmHg or \>=95mmHg, or tachycardia (PR\>=100times/min)
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
* smokers
* can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes