Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Metformin
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...