| Trial ID: | L3588 |
| Source ID: | NCT01728740
|
| Associated Drug: |
Acarbose/Metformin Fdc (Bay81-9783)
|
| Title: |
Bioequivalence Study for Acarbose / Metformin FDC
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type II
|
| Interventions: |
DRUG: Acarbose/Metformin FDC (BAY81-9783)|DRUG: Acarbose (Glucobay, BAYG5421)|DRUG: Metformin
|
| Outcome Measures: |
Primary: 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 |
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
|
| Start Date: |
2012-09
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2012-12-19
|
| Locations: |
Seoul, 110-744, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01728740
|
