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Clinical Trial Details

Trial ID: L3848
Source ID: NCT04065581
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 2
Interventions: DRUG: Acarbose/Metformin FDC(BAY81-9783)|DRUG: Glucobay|DRUG: Glucophage
Outcome Measures: Primary: RatioCmax (serum glucose), RatioCmax=Cmax,day1/ Cmax,day-1 Cmax,day-1: Maximum serum glucose after 75g sucrose loading on Day -1 Cmax,day1: Maximum serum glucose after 75g sucrose loading and single dose administration of study drug on Day 1, Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes|RatioAUC(0-4) (serum glucose), RatioAUC(0-4)=AUC(0-4),day1/AUC(0-4),day-1 AUC (0-4),day1: AUC of serum glucose from time 0 to 4 hours on Day 1 AUC(0-4),day-1: AUC of serum glucose from time 0 to 4 hours on Day -1, Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes|Cmax (plasma metformin), Cmax: Maximum observed drug concentration in measured matrix after single dose administration / maximum drug concentration in plasma after single dose administration, Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours|AUC (0-tlast) (plasma metformin), AUC (0-tlast): AUC from time 0 to the last data point \> LLOQ (lower limit of quantification), Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours|AUC (plasma metformin), AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose, Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours | Secondary: Frequency of TEAE (treatment-emergent adverse event), Approximate 20 days
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2019-10-14
Completion Date: 2020-03-06
Results First Posted:
Last Update Posted: 2020-04-13
Locations: Zhongshan Hospital, Fudan University, Shanghai, 200032, China
URL: https://clinicaltrials.gov/show/NCT04065581