Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test GIR · 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.
Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.
| Arm | Type | Description |
|---|---|---|
| First Test GIR (Fasting), Then Reference GIR (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
| First Reference GIR (Fasting), Then Test GIR (Fasting) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
| First Test GIR (Fed), Then Reference GIR (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| First Reference GIR (Fed), Then Test GIR (Fed) | EXPERIMENTAL | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Test GIR | DRUG | Participants received 500 milligrams (mg) test GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
| Reference GIR | DRUG | Participants received 500 mg reference GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
Inclusion Criteria: * Participants had given written informed consent before any trial-related activities * Chinese male and female participants (at least 1/4 of each gender per trial group) * Aged between 18 and 55 years, inclusive * Weighed: 50 to 80 kilogram (kg); Body mass index (BMI): 18 to 30...
Test GIR is an investigational small molecule being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, as part of a bioequivalence study conducted in China.
Test GIR is being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed bioequivalence study in China. The drug is not yet approved and remains investigational.
Test GIR is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug in healthy volunteers.
Test GIR is in Phase 1 clinical development. It has completed one Phase 1 trial, a bioequivalence study in China involving 44 healthy volunteers. The drug is investigational and has not been approved.
Test GIR has one completed clinical trial, NCT03393208, titled 'Glucophage Immediate Release (GIR) China Bioequivalence Study'. This Phase 1 study enrolled 44 healthy volunteers in China and was a controlled, randomized trial.
Test GIR is being studied as a bioequivalent version of Glucophage Immediate Release. The clinical trial NCT03393208 is designed to assess bioequivalence between Test GIR and Glucophage Immediate Release in healthy volunteers.