A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin

A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers

This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.

Inclusion Criteria:

• Age between 19 to 45, healthy male subjects(at screening)
• Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
• Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

• Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
• Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
• Serum AST(SGOT), ALT(SGPT)>1.5 times upper limit of normal range
• MDRD eGFR <80mL/min/1.73m2
• Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
• Subject who already participated in other trials in 3 months
• Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.