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...