TABLE 1.
Summary of PK parameters for CG beta after single and multiple administration to women in part 1 and part 2 of the trial
|
PK parameters: Single dose of CG beta administration to women |
CG beta 16 µg N = 5 |
CG beta 64 µg N = 5 |
CG beta 128 µg N = 5 |
CG beta 256 µg N = 5 |
|---|---|---|---|---|
| AUCinf (h*ng/ml) a | 27.8 (22) | 144 (40) | 288 (41) | 563 (10) |
| AUCt (h*ng/ml) a | 18.4 (32) | 132 (42) | 275 (38) | 553 (10) |
| Cmax (ng/ml) a | 0.305 (28) | 1.37 (51) | 2.94 (18) | 7.74 (47) |
| Tmax (h) b | 24 [14; 36] | 24 [14; 48] | 24 [16; 36] | 16 [2; 24] |
| t1/2 (h) a | 46.0 (16) | 47.0 (11) | 46.8 (28) | 42.0 (13) |
| CL/F (L/h) a | 0.576 (17) | 0.445 (50) | 0.445 (31) | 0.455 (10) |
| Vz/F (L) a | 38.3 (27) | 30.2 (48) | 30.0 (18) | 27.6 (12) |
|
PK parameters: Multiple doses of CG beta administration for 10 days to women |
CG beta 8 µg N = 6 |
CG beta 16 µg N = 6 |
|---|---|---|
| AUCτ (h*ng/ml) a | 15.0 (35) | 41.9 (22) |
| Cmax (ng/ml) a | 0.694 (32) | 1.90 (21) |
| Tmax (h) b | 8 [5; 12] | 11 [10; 16] |
| t1/2 (h) a | 43.5 (16) | 40.8 (14) |
| CL/F (L/h) a | 0.534 (40) | 0.382 (26) |
| Vz/F (L) a | 33.5 (51) | 22.5 (21) |
Abbreviations: AUCinf, area under the concentration‐time curve from time zero to infinity; AUCt, area under the concentration‐time curve from time zero to time of last measurable concentration (above the lower limit of quantification); AUC, area under the concentration‐time curve during a dosing interval at steady‐state; CG, chorionic gonadotropin; CL/F, apparent clearance; Cmax, peak plasma concentration; PK, pharmacokinetic; t1/2, terminal half‐life; Tmax, time to peak plasma concentration; Vz/F, apparent distribution volume.
Geometric mean (coefficient of variation%),
Median [range], N = number of subjects.