Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000904-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose (Glucobay ODT, BAYG5421) | Drug | Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load | |
| Difference of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum drug concentration in plasma after single dose (tmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load | |
| Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acarbose (Glucobay ODT, BAYG5421) | Drug | Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water |
|
| Acarbose (Glucobay, BAYG5421) | Drug | Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet; Day 2: oral sucrose load plus Glucobay standard tablet taken with water |
|
| within 4 hours after sucrose load |
| Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load |
| Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided