Table 5.
Dose proportionality assessment for pharmacokinetic parameters of metformin at three doses (test treatments T1–T3) in the presence of 10 mg rosuvastatin
| Endpoint | Test (T) | Reference (REF) | Ratio T/REF | 90% CI | Dose ratio | (T/REF) as a fraction of dose ratio | ||
|---|---|---|---|---|---|---|---|---|
| T2 (50 mg metformin) | T1 (10 mg metformin) | |||||||
| N | Adj. gMean | N | Adj. gMean | |||||
| AUC0–tz (nmol·h/L) | 16 | 6382.07 | 15 | 1554.00 | 4.11 | (3.87; 4.36) | 5 | 0.822 |
| C max (nmol/L) | 16 | 990.39 | 15 | 273.27 | 3.62 | (3.16; 4.15) | 5 | 0.724 |
| AUC0–∞ (nmol·h/L) | 16 | 6418.12 | 12 | 1559.11 | 4.12 | (3.83; 4.43) | 5 | 0.824 |
| Endpoint | Test (T) | Reference (REF) | Ratio T/REF | 90% CI | Dose ratio | (T/REF) as a fraction of dose ratio | ||
|---|---|---|---|---|---|---|---|---|
| T3 (500 mg metformin) | T2 (50 mg metformin) | |||||||
| N | Adj. gMean | N | Adj. gMean | |||||
| AUC0–tz (nmol·h/L) | 15 | 50027.10 | 16 | 6333.14 | 7.90 | (7.55; 8.27) | 10 | 0.790 |
| C max (nmol/L) | 15 | 7129.32 | 16 | 999.06 | 7.14 | (6.54; 7.78) | 10 | 0.714 |
| AUC0–∞ (nmol·h/L) | 15 | 50491.90 | 16 | 6374.86 | 7.92 | (7.58; 8.28) | 10 | 0.792 |
| Endpoint | Test (T) | Reference (REF) | Ratio T/REF | 90% CI | Dose ratio | (T/REF) as a fraction of dose ratio | ||
|---|---|---|---|---|---|---|---|---|
| T3 (500 mg metformin) | T1 (10 mg metformin) | |||||||
| N | Adj. gMean | N | Adj. gMean | |||||
| AUC0–tz (nmol·h/L) | 15 | 50547.30 | 15 | 1553.37 | 32.54 | (31.12; 34.03) | 50 | 0.651 |
| C max (nmol/L) | 15 | 7193.55 | 15 | 266.59 | 26.98 | (23.95; 30.40) | 50 | 0.540 |
| AUC0–∞ (nmol·h/L) | 15 | 51017.10 | 12 | 1537.88 | 33.17 | (31.24; 35.22) | 50 | 0.663 |
AUC 0–tz area under the plasma concentration–time curve from time zero to last quantifiable concentration, C max peak plasma concentration, AUC 0–∞ area under the plasma concentration–time curve extrapolated to infinity, CI confidence interval, Adj. gMean adjusted geometric mean