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To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acarbose/Metformin FDC | Experimental | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin) |
|
| Acarbose+Metformin | Active Comparator | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg |
|
| Acarbose | Active Comparator | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg |
|
| Metformin | Active Comparator | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose/Metformin FDC (BAY81-9783) | Drug | Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0) | within 4 hours after sucrose load | |
| Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0) | within 4 hours after sucrose load | |
| Cmax of metformin | within 24 hours after dosing | |
| AUC(0-tn) of metformin | within 24 hours after dosing |
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Inclusion Criteria:
Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)
Results of the 75 g oral glucose tolerance test (OGTT) during screening show:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Acarbose (Glucobay, BAYG5421) | Drug | Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose |
|
| Metformin | Drug | Metformin 500mg, oral, single dose |
|
| D004700 | Endocrine System Diseases |
| D001645 |
| Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |