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

Seoul National University

Status and phase

Completed

Phase 1

Conditions

Human Microbiome

Treatments

Drug: Cholestyramine Resin

Study type

Interventional

Funder types

Other

Identifiers

NCT04335526

MMP2

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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