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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Metformin/Vancomycin |
|
| Part 2 | Experimental | Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin (part 1) | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the gut microbiome species change | Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing | Day 1/4/16/19 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the maximum plasma concentration (Cmax) of metformin | Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Yong Chung | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNUBH Clinical trial centor | Seongnam-si | Gyeonggi-do | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33982376 | Derived | Kim E, Kim AH, Lee Y, Ji SC, Cho JY, Yu KS, Chung JY. Effects of vancomycin-induced gut microbiome alteration on the pharmacodynamics of metformin in healthy male subjects. Clin Transl Sci. 2021 Sep;14(5):1955-1966. doi: 10.1111/cts.13051. Epub 2021 May 31. |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D006020 |
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|
| Vancomycin | Drug | 11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid |
|
|
| Metformin (part 2) | Drug | 1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch) |
|
|
Compare the area under the plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment |
| Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose) |
| Compare the maximum blood glucose concentration (Gmax) | Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment | Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) |
| Compare the area under the blood glucose concentration versus time curve (AUC) | 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 | Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) |
| Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |