Status:
COMPLETED
A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin
Lead Sponsor:
Seoul National University Hospital
Conditions:
Human Microbiome
Eligibility:
MALE
19-45 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03809260
Start Date
December 1 2018
End Date
February 28 2019
Last Update
October 8 2020
Active Locations (1)
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1
SNUBH Clinical trial centor
Seongnam-si, Gyeonggi-do, South Korea, 03080