Human Microbiome
Conditions
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 in healthy male volunteers.
Interventions
DRUGMetformin (part 1)
1\ 4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d\ 19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).
DRUGVancomycin
11d: Vancomycin 250 mg bid, 12\ 17d: Vancomycin 500 mg bid
DRUGMetformin (part 2)
1\ 4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the gut microbiome species change | Day 1/4/16/19 | Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the maximum plasma concentration (Cmax) of metformin | Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose) | Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment |
| Compare the area under the plasma concentration versus time curve (AUC) of metformin | Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose) | Compare the area under the plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment |
| Compare the maximum blood glucose concentration (Gmax) | Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) | Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment |
| Compare the area under the blood glucose concentration versus time curve (AUC) | Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) | Oral glucose tolerance test (OGTT); Compare the area under the blood glucose concentration versus time curve (AUC) before and after metformin (or vancomycin) PO treatment |
Countries
South Korea
Outcome results
None listed