Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gliclazide · 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...
Gliclazide is being studied for use in healthy participants. It is an investigational small molecule currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial to assess bioequivalence and potential drug-drug interactions when combined with metformin.
Gliclazide is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development for use in healthy participants.
Gliclazide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 40 healthy participants.
Gliclazide has one completed clinical trial, NCT03467945, titled "Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants." This Phase 1 study enrolled 40 healthy volunteers in Germany and was a controlled, randomized trial.
No, Gliclazide is not the same as Metformin. They are separate drugs being studied together in a clinical trial to evaluate their bioequivalence and potential drug-drug interactions. The trial combines both medications in healthy participants.