Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Test GIR, Reference GIR
Metformin · 2 trials · 1 indication
AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Participants received single oral dose of metformin 1000 milligram (mg) and gliclazide 30 mg fixed combination tablet in treatment period 1 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg in treatment period 3 and then a single oral dose of gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| Treatment Sequence 2 | EXPERIMENTAL | Participants received concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 1 followed by single oral dose of gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 3 and then single oral dose of metformin 1000 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| Treatment Sequence 3 | EXPERIMENTAL | Participants received single oral dose of metformin 1000 mg in treatment period 1 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 2 followed by single oral dose of gliclazide 30 mg in treatment period 3 and then concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| Treatment Sequence 4 | EXPERIMENTAL | Participants received single oral dose of gliclazide 30 mg in treatment period 1 followed by single oral dose of metformin 1000 mg in treatment period 2 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 3 and then single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| First Test GIR (Fasting), Then Reference GIR (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
| First Reference GIR (Fasting), Then Test GIR (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
| First Test GIR (Fed), Then Reference GIR (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| First Reference GIR (Fed), Then Test GIR (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Metformin/Gliclazide Fixed Combination | DRUG | Participants received single oral dose of Metformin and Gliclazide fixed combination tablet in treatment period 1, 2, 3 or 4. |
| Metformin | DRUG | Participants received single oral dose of Metformin tablet in treatment period 1, 2, 3 or 4. |
| Gliclazide | DRUG | Participants received single oral dose of Gliclazide tablet in treatment period 1, 2, 3 or 4. |
| Test GIR | DRUG | Participants received 500 milligrams (mg) test GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
| Reference GIR | DRUG | Participants received 500 mg reference GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
Inclusion Criteria: * Participants has given written informed consent before any study-related activities were carried out * Ethnic origin: Mexicans * Weight between 55 and 95 kilogram (kg) * Body mass index between 18.5 and 27 kilogram per meter square (kg/m\^2) * Not smoking more than 5 cigarette...
Metformin/Gliclazide Fixed Combination is an investigational small molecule drug candidate developed by Merck KGaA. It combines metformin and gliclazide into a single fixed-dose formulation. The specific therapeutic indication for this combination has not been disclosed. It is currently in Phase 1 clinical development.
Metformin/Gliclazide Fixed Combination targets the mitochondrial proteins MT-ND6, NDUFA10, NDUFS8, MT-ND4L, NDUFA6, and MT-ND1. It acts as an inhibitor of these targets. These proteins are components of the mitochondrial respiratory chain complex I.
Metformin/Gliclazide Fixed Combination is being developed by Merck KGaA, which trades under the ticker MKGAF. Merck KGaA is the sponsor of the clinical program for this fixed-dose combination.
Metformin/Gliclazide Fixed Combination is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial.
Metformin/Gliclazide Fixed Combination has been studied in one completed Phase 1 trial, NCT03467945, titled Bioequivalence and Drug-Drug Interaction Study of Metformin/Gliclazide in Healthy Participants. The trial enrolled 40 healthy volunteers in Germany and was randomized and controlled.
Metformin/Gliclazide Fixed Combination is also known as Metformin (10mg) and Metformin. It is a fixed-dose combination product that contains metformin along with gliclazide, so it is not the same as metformin alone.