Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glucobay · 1 trial · 1 indication
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
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
Cmax: Maximum observed drug concentration in measured matrix after single dose administration / maximum drug concentration in plasma after single dose administration
AUC (0-tlast): AUC from time 0 to the last data point \> LLOQ (lower limit of quantification)
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
| Arm | Type | Description |
|---|---|---|
| Treatment A-washout-treatment B | EXPERIMENTAL | Subject will receive a single oral dose of acarbose/metformin FDC (Treatment A, 50 mg acarbose/500 mg metformin) in period 1, followed by a single oral dose of 50mg acarbose and 500mg metformin as loose combination (Treatment B) in period 2. Washout interval between 2 treatment periods was at least 7 days. |
| Treatment B-washout-treatment A | EXPERIMENTAL | Subject will receive a single oral dose of 50 mg acarbose and 500 mg metformin as loose combination (Treatment B) in period 1, followed by a single oral dose of acarbose/metformin FDC (Treatment A, 50mg acarbose/500 mg metformin) in period 2. Washout interval between 2 treatment periods was at least 7 days. |
| Name | Type | Description |
|---|---|---|
| Acarbose/Metformin FDC(BAY81-9783) | DRUG | Single dose: 50 mg acarbose/500 mg metformin tablet, oral |
| Glucobay | DRUG | Single dose: 50 mg tablet, oral |
| Glucophage | DRUG | Single dose: 500 mg tablet, oral |
Inclusion Criteria: * Chinese healthy male or non-pregnant, non-lactating female subject, age ≥ 18 years at the first screening examination / visit. * Body Mass Index (BMI): ≥ 19 to \<28 kg / m\*2 , with body weight ≥ 50 kg. * Results of HbA1c value are within the normal range (4.0-6.0%, inclusive)...
Glucobay is used for the treatment of Diabetes Mellitus, Type 2. It is a small molecule developed by Bayer AG for the metabolic therapeutic area. The drug is currently in Phase 1 clinical development, with one completed trial involving 24 participants.
Glucobay is developed by Bayer AG, a company traded under the ticker BAYRY. The drug is a small molecule intended for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development.
Glucobay is in Phase 1 clinical development. It has one completed trial, NCT04065581, which was a bioequivalence study for an acarbose/metformin fixed-dose combination. The drug is investigational and not yet approved.
Glucobay has one completed clinical trial, NCT04065581, titled 'Bioequivalence Study for Acarbose/Metformin FDC'. This Phase 1 study enrolled 24 participants with Type 2 Diabetes Mellitus in China, with healthy volunteers allowed. The trial was controlled but not double-blind.
Glucobay is associated with acarbose, as the completed trial NCT04065581 studied an acarbose/metformin fixed-dose combination. However, the drug name Glucobay itself is not explicitly stated to be an alternative name for acarbose in the available information.