Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Glucophage® XR RM Test
Glucophage RM Test · 1 trial · 1 indication
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.
Cmax was obtained directly from the concentration versus time curve.
| Arm | Type | Description |
|---|---|---|
| First Reference GXR (Fasting), Then Test GXR RM (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 milligram (mg) of reference GXR (Glucophage® Extended Release) tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg test GXR RM (Reduced Mass) tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
| First Test GXR RM (Fasting), Then Reference GXR (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
| First Reference GXR (Fed), Then Test GXR RM (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 milligrams (mg) of reference GXR tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of test GXR RM tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| First Test GXR RM (Fed), Then Reference GXR (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| Name | Type | Description |
|---|---|---|
| Glucophage® XR RM Test | DRUG | Participants received a single oral dose of 500 mg of test Glucophage® XR RM tablet under fasting or fed conditions. |
| Glucophage® XR Reference | DRUG | Participants received a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions. |
Inclusion Criteria: * All values for hematology and biochemistry tests of blood and urinalysis (especially Estimated Glomerular Filtration Rate \[eGFR\] greater than \[\>\] 80 milliliters per minute per 1.73 square meter \[80 ml/min/1.73 m\^2\] and normal Creatinine) within the normal range or show...
Glucophage RM Test is an investigational small molecule developed by Merck KGaA. It has been studied in a Phase 1 bioequivalence trial in healthy adult volunteers in South Korea. The specific therapeutic indication for this asset has not been disclosed, and it remains in clinical development rather than approved for marketing.
Glucophage RM Test is developed by Merck KGaA, which trades over the counter in the United States under the ticker MKGAF. Merck KGaA is the sponsor associated with the clinical program for this asset.
Glucophage RM Test is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not been approved by the FDA, so Glucophage RM Test remains an investigational product rather than a marketed medicine.
Glucophage RM Test has been evaluated in one completed Phase 1 study, NCT04684420, titled the GXR RM (Glucophage Extended Release Reduced Mass) 500 mg Korea Bioequivalence Study. It enrolled 81 healthy adult volunteers in South Korea, used a randomized controlled design, and included both male and female participants aged 19 years and older.
Yes, Glucophage RM Test is also known as Glucophage XR RM Test. The two names refer to the same Merck KGaA asset, which has been studied in a Phase 1 bioequivalence trial of the extended release reduced mass 500 mg formulation in healthy volunteers in South Korea.
Glucophage RM Test has been studied in healthy volunteers rather than in patients with a disclosed disease. Its Phase 1 trial, NCT04684420, enrolled 81 healthy adults in South Korea to assess bioequivalence of the 500 mg extended release reduced mass formulation. No therapeutic indication has been disclosed for this asset.