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 |