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Table 2 Pharmacokinetic endpoints of drospirenone after an oral single dose of 4 mg drospirenone administered after food intake and under fasting conditions (geometric mean, arithmetic mean, SD, CV, lower and upper ranges, median, n = 24)

From: Evaluation of the food effect on a drospirenone only contraceptive containing 4 mg administered with and without high-fat breakfast in a randomised trial

Drospirenone

Variable

Geom mean

Arithm mean

SD

CV

Range

Median

N

TEST ‘A’ (with food)

AUC(0-72 h) [ng*h/mL]

479.28

487.93

96.00

19.7

311.46—733.36

462.40

24

Cmax [ng/mL]

34.98

36.19

9.83

27.1

20.60—59.39

35.42

24

tmax [h]

2.698

2.896

1.343

46.4

2.000- 8.000

2.500

24

TEST ‘B’ (without food)

AUC(0-72 h) [ng*h/mL]

443.83

452.38

91.13

20.1

303.76—671.67

438.23

24

Cmax [ng/mL]

27.04

27.53

5.17

18.8

17.99—35.02

28.24

24

tmax [h]

3.944

4.063

0.958

23.6

2.500—6.000

4.500

24

  1. CV coefficient of variation. AUC(0–72) Area under the concentration/time curve from time 0 h to the last observed concentration at 72 h. Tmax timepoint of maximal concentration; Cmax observed maximal concentration after administration