Table 2.
Summary of metformin pharmacokinetics
| Parameter | Treatment | N | Geometric LS means | Ratio of means | 90% CI | P value |
|---|---|---|---|---|---|---|
| AUC0–∞ (ng.hour/mL) | Placebo + 1,000 mg metformin (reference) | 30 | 12,245 | 1.37 | 1.28−1.46 | NA |
| 400 mg abemaciclib + 1,000 mg metformin (test) | 28 | 16,718 | ||||
| Cmax (ng/mL) | Placebo + 1,000 mg metformin (reference) | 30 | 1,586 | 1.22 | 1.13−1.30 | NA |
| 400 mg abemaciclib + 1,000 mg metformin (test) | 28 | 1,930 | ||||
| CLR (L/hour) | Placebo + 1,000 mg metformin (reference) | 30 | 21.5 | 0.550 | 0.504−0.600 | NA |
| 400 mg abemaciclib + 1,000 mg metformin (test) | 28 | 11.8 | ||||
| CLRS (L/hour) | Placebo + 1,000 mg metformin (reference) | 29 | 16.0 | 0.381 | 0.323−0.450 | NA |
| 400 mg abemaciclib + 1,000 mg metformin (test) | 25 | 6.08 | ||||
| Tmax (hour) | Placebo + 1,000 mg metformin (reference) | 24 | 3.03a | 0.500b | 0−0.983c | 0.070 |
| 400 mg abemaciclib + 1,000 mg metformin (test) | 24 | 3.76a |
CLRS was calculated using Eq. 3 and assumes no renal tubular reabsorption.AUC0–∞, area under the concentration‐time curve from zero to infinity; CI, confidence interval; CLR, renal clearance; CLRS, clearance of renal secretion; Cmax, peak plasma concentration; LS, least squares; NA, not applicable; Tmax, time of maximum plasma concentration.
aMedian. bMedian of differences. cApproximate 90% CI.