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Clinical Trial Details

Trial ID: L5871
Source ID: NCT01554631
Associated Drug: Acarbose (Glucobay Odt, Bayg5421)
Title: A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Acarbose (Glucobay ODT, BAYG5421)|DRUG: Acarbose (Glucobay, BAYG5421)
Outcome Measures: Primary: Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0), within 4 hours after sucrose load|Ratio of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0), within 4 hours after sucrose load | Secondary: Difference in postprandial maximum concentration (Cmax) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0), within 4 hours after sucrose load|Difference in postprandial area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0), within 4 hours after sucrose load|Safety parameters, Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG), Assessed in pre study treatment, study treatment, and follow-up visits
Sponsor/Collaborators: Sponsor: Bayer
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 34
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2012-03
Completion Date: 2012-05
Results First Posted:
Last Update Posted: 2013-06-14
Locations: Mönchengladbach, Nordrhein-Westfalen, 41061, Germany
URL: https://clinicaltrials.gov/show/NCT01554631

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress