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. 2022 Oct 3;27(19):6534. doi: 10.3390/molecules27196534

Table 3.

Pharmacokinetic parameters of misoprostol acid in clinical trials.

Dose (Route) Number of Participants Type of Biological Sample Mean Time
of Maximum Concentration (Tmax) [Time Min]
Mean Maximum
Drug Concentration (Cmax) [Pg/Ml]
Ref.
400 µg
(oral)
45 human plasma 15.0 ± 4.8 777.74 ± 259.80 [30]
200 µg
(oral)
10 human milk 66.0 ± 12.0 7.6 ± 2.8 [31]
400 µg
(sublingual)
10 human plasma 26.0 ± 11.5 574.8 ± 250.7 [32]
400 µg
(oral)
10 27.5 ± 14.8 287.6 ± 144.3
400 µg
(vaginal)
10 72.0 ± 34.5 125.2 ± 53.8
400 µg
(vaginal+water)
10 75.0 ± 31.6 162.8 ± 57.1
400 µg slow release
(oral)
10 human plasma 54.0 ± 46.5 27.2 ± 14.5 [33]
800 µg slow release
(oral)
11 81.8 ± 111.5 43.5 ± 17.7
400 µg
(oral)
10 36.0 ± 12.6 186.2 ± 118.8
400 µg
(oral)
9 human plasma 14.2 ± 7.0 258.7 ± 83.8 [34]
400 µg
(rectal)
9 71.7 ± 23.5 86.8 ± 44.7
400 µg
(vaginal)
9 65.0 ± 21.2 210.8 ± 63.0
400 µg
(oral)
10 human plasma 34.0 ± 17.0 277.0 ± 124.0 [8]
400 µg
(vaginal)
10 80.0 ± 27.0 165.0 ± 86.0
400 µg
(vaginal)
10 human serum 91.5 ± 82.0 445.9 ± 428.7 [35]
400 µg
(vaginal)
10 51.0 ± 20.2 427.1 ± 235.5
400 µg
(buccal)
10 84.0 ± 81.9 264.8 ± 170.7
400 µg
(rectal)
10 19.5 ± 14.2 202.2 ± 195.7
800 µg slow release
(oral)
11 human serum 96.0 ± 168 78.8 ± 51.1 [36]
400 µg
(sublingual)
9 30.0 ± 0.0 580 ± 178.1
400 µg
(vaginal)
10 102.0 ± 72.0
117.7 ± 42.1
400 µg
(vaginal)
14 human serum 120 ± 90 262.6 ± 201.1 [37]
400 µg
(vaginal) misoprostol tablets moistened with 3 mL of
saline solution
14 56.8 ± 45.6 1092.4 ± 1538.3
400 µg
(vaginal) misoprostol tablets moistened with
3 mL of 5% acetic acid
14 52.5 ± 37.16 703.4 ± 464.6
800 µg
(sublingual)
10 human plasma 30.0 1140 (817–2060) [38]
800 µg
(buccal)
8 30.0 229 (140 –1160)
800 µg
(oral)
10 human serum 20.7 ± 11.16 2683.0 ± 1216.1 [39]
800 µg
(sublingual)
10 42.72 ± 24.9 2439.1 ± 1156.7
800 µg
(buccal)
10 78.48 ± 37.44 1361.1 ± 343.6
600 µg
(rectal)
10 human serum 40.5 ± 15.9 184.0 ± 64.5 [40]
600 µg
(oral)
10 18.0 ± 8.8 327.9 ± 102.9