Table 4 Metformin plasma PK parameters

From: Letrozole, abemaciclib and metformin in endometrial cancer: a non-randomized phase 2 trial

Day

Cmax(µg/L)

Tmax(h)

t½(h)

AUC0-ta(mg/L•h)

Cl(L/h)

Cmin-pre(µg/L)

Cmin-24h(µg/L)

Cmin -foldpre

vs D1 pre24 h

1

1298 (1.17)

3.6 (1.3)

6.4 (1.2)

13.3 (1.30)

37.7 (1.30)

79.8 (2.13)

132 (1.78)

1 (-)

1.65 (1.35)

8

1603 (1.33)

3.6 (1.3)

7.3 (1.3)

20.2c (1.51)

24.7 (1.51)

258 (2.10)

258 (1.91)

3.24 (1.48)

3.23 (1.40)

P-valueb

0.11

-

0.059

0.003

-

  

-

0.0096

        

0.0008

0.0004

  1. aOn day 1, the 8th day of daily metformin dosing, abemaciclib and letrozole daily dosing was started. Therefore, clearance values are based on AUC0-t, where t = 24 h.
  2. bBy paired t-test (two-sided) on log-transformed values not corrected for multiple testing. P-values are listed under Cmax, t½, and AUC for day 8 vs day 1 comparison for these parameters, respectively. P-values for Cmin fold differences, each relative to the D1 pre value, are listed in a repeating table lay-out below the fold values.
  3. cCaverage at steady-state (Cav,ss) on day 8 was 842 µg/L.
  4. SD, geometric standard deviation.
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