A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles

• Status: Completed
• Trial end date: 2020-10-21
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers

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

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Bile Acids and Salts; Cholestyramine Resin; Metformin

Criteria

Inclusion Criteria:

• Age between 19 to 50, 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)>2 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