Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Metformin hydrochloride
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 developed by Merck KGaA. It has been studied in a Phase 1 bioequivalence trial conducted in China in healthy adult volunteers. Its therapeutic indication has not been disclosed, and the compound remains in clinical development rather than being an approved medicine.
Test GXR is being developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the Phase 1 bioequivalence study of the compound conducted in China. No partnership or licensing arrangement for Test GXR has been announced.
Test GXR is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond early-stage testing, and the compound is investigational rather than approved for any use.
Test GXR has been evaluated in one completed Phase 1 trial, NCT03566810, titled Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt). The trial enrolled 54 healthy adult volunteers in China, used a randomized controlled design, and included both male and female participants aged 18 years and older.
The Test GXR Phase 1 trial NCT03566810 was a randomized, controlled bioequivalence study conducted in China. It enrolled 54 healthy volunteers of both sexes, aged 18 years and older. The study was not double blinded, and it has been completed. No efficacy results from the trial have been disclosed.