check_circleStudy Completed
Diabetes Mellitus, Type 2
Bayer Identifier:
19843
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Bioequivalence study for acarbose/metformin FDC
Trial purpose
The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and metformin (500 mg)
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
24Trial Dates
October 2019 - March 2020Phase
Phase 1Could I Receive a placebo
NoProducts
Glucobay M (Acarbose/Metformin, BAY81-9783)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Zhongshan Hospital, Fudan University | Shanghai, 200032, China |
Primary Outcome
- 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 1date_rangeTime Frame: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 -1date_rangeTime Frame: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 administrationdate_rangeTime Frame: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)date_rangeTime Frame: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) dosedate_rangeTime Frame: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 Outcome
- Frequency of TEAE (treatment-emergent adverse event)date_rangeTime Frame:Approximate 20 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2