Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Metformin/Gliclazide Fixed Combination · 1 trial · 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).
| 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. |
| 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. |
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...