Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test GXR · 1 trial · 1 indication
Area under the plasma concentration versus 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.
Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.
| Arm | Type | Description |
|---|---|---|
| First Test GXR (Fasting), Then Reference GXR (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 milligrams (mg) of test GXR tablet (Merck Nantong/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GXR (Merck Darmstadt/Germany) on Day 8 in treatment period 2 under fasting conditions. There was a wash-out period of 7 days between each treatment period. |
| First Reference GXR (Fasting), Then Test GXR (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/Germany) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GXR (Merck Nantong/China) on Day 8 in treatment period 2 under fasting conditions. There was a wash-out period of 7 days between each treatment period. |
| First Test GXR (Fed), Then Reference GXR (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GXR (Merck Darmstadt/Germany) on Day 8 in treatment period 2 under fed conditions. There was a wash-out period of 7 days between each treatment period. |
| First Reference GXR (Fed), Then Test GXR (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/Germany) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GXR (Merck Nantong/China) on Day 8 in treatment period 2 under fed conditions. There was a wash-out period of 7 days between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Test GXR | DRUG | Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
| Reference GXR | DRUG | Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
Inclusion Criteria: * Overtly healthy as determined by medical evaluation, including medical history and a physical examination * Have a body weight within 50 to 90 kilogram (kg) and Body mass index (BMI) within the range 18 to 30 kg per meter square (kg/m\^2) (inclusive) * Chinese male and female ...
Test GXR is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial in China. The drug is being developed by Merck KGaA.
Test GXR is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers in China.
Test GXR is in Phase 1 clinical development. It has one completed trial, NCT03566810, which enrolled 54 healthy volunteers in China. The drug is investigational and has not been approved by regulatory authorities.
Test GXR has one completed clinical trial, NCT03566810, titled "Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)." This Phase 1 study enrolled 54 healthy volunteers in China and was a controlled, randomized trial.
Test GXR is being studied as Glucophage Extended Release (GXR) in the clinical trial NCT03566810. The trial is a bioequivalence study comparing the drug in healthy volunteers in China. Merck KGaA is the developer.