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

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Metformin; Vancomycin

Criteria

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.