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

Dong-A Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Diabetes Mellitis Type 2

Treatments: Drug: Placebo; Drug: DA-1229

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961025

DA1229_DM_I

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

DA-1229

Experimental group

Description:

DA-1229

Treatment:

Drug: DA-1229