check_circleStudy Completed

Diabetes Mellitus, Type 2

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

All

Age

18 - N/A

Trial summary

Enrollment Goal
24
Trial Dates
October 2019 - March 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Zhongshan Hospital, Fudan UniversityShanghai, 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 1
    date_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 -1
    date_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 administration
    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 (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) dose
    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

Secondary Outcome

  • Frequency of TEAE (treatment-emergent adverse event)
    date_rangeTime Frame:
    Approximate 20 days

Trial design

Randomized, non-blinded crossover study to establish the bioequivalence between fixed dose combination (FDC) and the loose combination of acarbose and metformin following single oral dosing in Chinese healthy adult male and female subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2