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Also known as Glucophage XR (Test drug), Test Glucophage® XR, Test Glucophage, Glucophage® XR Reference, Glucophage Reference
Glucophage · 2 trials · 1 indication
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration.
| Arm | Type | Description |
|---|---|---|
| First Test GXR RM (Fasted), Then Reference GXR RM (Fasted) | EXPERIMENTAL | Participants will receive a single dose of Test Glucophage Extended Release Reduced Mass (GXR RM) tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. |
| First Reference GXR RM (Fasted), Then Test GXR RM (Fasted) | EXPERIMENTAL | Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. |
| First Test GXR RM (Fed), Then Reference GXR RM (Fed) | EXPERIMENTAL | Participants will receive a single dose of Test GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. |
| First Reference GXR RM (Fed), Then Test GXR RM (Fed) | EXPERIMENTAL | Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. |
| First Glucophage XR (Test), Then Glucophage XR (Comparator) | EXPERIMENTAL | Participants received single oral dose of 750 milligram (mg) Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) in treatment period 1 followed by single oral dose of 750 mg Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) in treatment period 2 under fasting conditions. The two periods were separated by a 7-day wash-out period. |
| First Glucophage XR (Comparator), Then Glucophage XR (Test) | EXPERIMENTAL | Participants received single oral dose of 750 milligram (mg) Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) in treatment period 1 followed by single oral dose of 750 mg Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) in treatment period 2 under fasting conditions. The two periods were separated by a 7-day wash-out period. |
| Name | Type | Description |
|---|---|---|
| Test Glucophage® XR | DRUG | Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions. |
| Reference Glucophage® XR | DRUG | Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions. |
| Glucophage XR (Test drug) | DRUG | Participants received single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions. |
| Glucophage XR (Comparator drug) | DRUG | Participants received single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions. |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator. * Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to ...
Test Glucophage is an investigational small molecule developed by Merck KGaA. It is in Phase 1 clinical development, with two completed Phase 1 trials in healthy volunteers. The specific therapeutic indication has not been disclosed.
Test Glucophage is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is responsible for the clinical development of the drug.
Test Glucophage is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA.
Test Glucophage has been studied in two completed Phase 1 trials: NCT05463094, a bioequivalence study in Germany with 84 healthy volunteers, and NCT03583385, a bioequivalence study in Indonesia with 48 healthy volunteers. Both trials are completed.
Test Glucophage is also known as Glucophage XR (Test drug), Glucophage, Test Glucophage XR, Glucophage XR Reference, and Glucophage Reference. These alternative names refer to the same investigational drug developed by Merck KGaA.