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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin alone | No Intervention | ||
| Metformin with cholestyramine | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholestyramine Resin | Drug | Change bile acid pool by cholestyramine treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the maximum blood glucose concentration (Gmax) | Compare the maximum blood glucose concentration (Gmax) between meformin alone and meformin with cholestyramine | Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) |
| Compare the maximum blood glucose concentration (Gmax) | Compare the area under the blood glucose concentration versus time curve (AUC) between meformin alone and meformin with cholestyramine | Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) |
| Compare the gut microbiome species change | Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine | Day 1/2/8/9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chung Jae Yong, MD, PhD | Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002792 | Cholestyramine Resin |
| ID | Term |
|---|---|
| D011137 | Polystyrenes |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| D001697 |
| Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |