Status:
COMPLETED
A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles
Lead Sponsor:
Seoul National University Hospital
Conditions:
Human Microbiome
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief 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 vol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04335526
Start Date
May 1 2020
End Date
October 21 2020
Last Update
March 17 2021
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seoul, South Korea