Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

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

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Metformin; Mitiglinide

Criteria

Inclusion Criteria:

• Healthy males

• Subject with adequate clinical laboratory test results (hematology, blood chemistry, serology, drug abuse, urinalysis etc.)

• Subject with normal results in blood pressure, pulse, body temperature and ECG test

• Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2

Exclusion Criteria:

• Clinically significant functional disorder or acute disease

• Chronic disease affecting the absorption, metabolism or excretion of drug

• Any study drug administration within 90 days before the first drug administration

• Use of medicine affecting drug metabolism (inhibition, induction) such as barbital, within 30 days before the first drug administration