| Trial ID: | L7277 |
| Source ID: | NCT01388153
|
| Associated Drug: |
Acarbose (Glucobay Odt, Bayg5421)
|
| Title: |
A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Acarbose (Glucobay ODT, BAYG5421)|DRUG: Acarbose (Glucobay ODT, BAYG5421)|DRUG: Acarbose (Glucobay, BAYG5421)
|
| Outcome Measures: |
Primary: 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 | Secondary: 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), 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
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
33
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
|
| Start Date: |
2011-06
|
| Completion Date: |
2011-08
|
| Results First Posted: |
|
| Last Update Posted: |
2013-08-28
|
| Locations: |
Mönchengladbach, Nordrhein-Westfalen, 41061, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01388153
|
