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Medroxyprogesterone Acetate
MPA 1.5 (40) 2.8 (54) 37.6 (30) 37 (30) 4.8 (31) 2.4 (50) 46.3 (39) 102 (28) BA* = Baseline adjusted
Cmax = peak plasma concentration
tmax = time peak concentration occurs t1/ 2 = apparent terminal-phase disposition half-life (0.693/ z)
AUC= total area under the concentration-time curve Text Continues Below
Table 2 summarizes the mean pharmacokinetic parameters for unconjugated and conjugated estrogens and medroxyprogesterone acetate following administration of 2 PREMPRO 0.45 mg/ 1.5 mg and 2 PREMPRO 0.3 mg/ 1.5 mg tablets to healthy, postmenopausal women. TABLE 2. PHARMACOKINETIC PARAMETERS FOR UNCONJUGATED AND CONJUGATED ESTROGENS (CE) AND MEDROXYPROGESTERONE ACETATE (MPA) DRUG 2 x 0. 3 mg CE/ 1. 5 mg MPA Combination
(n = 30)
2 x 0.45 mg CE/ 1. 5 mg MPA Combination
(n = 61) PK Parameter Arithmetic Mean (% CV)
Cmax (pg/ mL) tmax (h) t1/ 2 (h) AUC (pgh/ mL) Cmax (pg/ mL) tmax (h) t1/ 2 (h) AUC (pgh/ mL) Unconjugated Estrogens Estrone 79
(35)
9.4
(86)
51.3
(30)
5029
(45)
91
(30)
9.8
(47)
48.9
(28)
5786
(42)
BA* -Estrone 56
(46)
9.4
(86)
19.8
(39)
1429
(49)
67
(37)
9.8
(47)
21.5
(49)
2042
(52)
Equilin 30
(43)
7.9
(42)
14.0
(75)
590
(42)
35
(40)
8.5
(34)
16.4
(49)
825
(44)
PK Parameter Arithmetic Mean (% CV)
Cmax (ng/ mL) tmax (h) t1/ 2 (h) AUC (ngh/ mL) Cmax (ng/ mL) tmax (h) t1/ 2 (h) AUC (ngh/ mL) Conjugated Estrogens Total Estrone 2. 4
(38)
7.1
(27)
26.5
(33)
62
(48)
3.0
(37)
8.2
(39)
25.9
(23)
78
(40)
BA* -Total
Estrone
2.2
(36)
7.1
(27)
16.3
(32)
41
(44)
2.8
(36)
8.2
(39)
16.9
(36)
56
(39)
Total Equilin 1. 5
(47)
5.5
(29)
11.5
(24)
22
(41)
1.9
(42)
7.2
(33)
12.2
(25)
31
(52)
PK Parameter Arithmetic Mean (% CV)
Cmax (ng/ mL) tmax (h) t1/ 2 (h) AUC (ngh/ mL) Cmax (ng/ mL) tmax (h) t1/ 2 (h) AUC (ngh/ mL) Medroxyprogesterone Acetate
MPA 1.2 (42) 2.8 (61) 42.3 (34) 29.4 (30) 1.2 (42) 2.7 (52) 47.2 (41) 32.0 (36) Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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