194–0.250 h) with a half-life between 40 and 48 min (0.674–0.798 h). C max is significantly higher for total (p = 0.003) and free testosterone (p = 0.003) after F2 administration compared with F1 dosing. Furthermore, it is observed that the average AUC with F2 dosing is significantly higher for free testosterone (p = 0.018) and not statistically significant for total testosterone (p = 0.078) compared with SN-38 mw the F1 dosing. The pharmacokinetic parameters of total and free testosterone and dihydrotestosterone after the different modes of administration are summarized in Table 2. Table 2 Pharmacokinetic parameters for total testosterone, free testosterone, and dihydrotestosterone after F1 and F2 administration Dosing
C max (ng/mL) T max (h) AUC(0–1,590) (ng*h/mL) T ½ (h) F1 total testosterone (ng/mL) 5.65 ± 2.35 0.256 ± 0.063 6.41 ± 2.23 0.726 ± 0.165 F2 total testosterone (ng/mL) 7.84 ± 3.69* 0.201 ± 0.043 8.10 ± 2.49 0.598 ± 0.080 F1 free testosterone (pg/mL) 36.2 ± 14.9 0.250 ± 0.083 35.1 ± 18.8 0.674 ± 0.187 F2 free testosterone (pg/mL) 52.4 ± 20.8* 0.194 ± 0.054 55.5 ± 31.1* 0.798 ± 0.247 F1 dihydrotestosterone Y-27632 (ng/mL) 0.519 ± 0.222 0.410 ± 0.105 1.39 ± 0.87 1.14 ± 0.49 F2 dihydrotestosterone (ng/mL) 0.578 ± 0.245 0.451 ± 0.066 1.17 ± 0.47
0.850 ± 0.336 For all calculations, the predose concentration is subtracted from the determined concentration after dosing. The values are mean ± SD. The means of F1 are calculated with the data of 13 women and the means of F2 are based on the data of 12 women To convert total testosterone to nanomoles per liter, multiply by 3.467 AUC area under the curve, C max Cl-amidine molecular weight maximum concentration, T max time PtdIns(3,4)P2 to maximum concentration, T ½ half-life * p < 0.05, value at F2 is significantly different from F1 The mean concentrations of testosterone, free testosterone, and dihydrotestosterone measured after sublingual administration of a single dose of testosterone (0.50 mg) after F1 and F2 administration are shown in the Figs. 1, 2 and 3. Fig. 1 Mean total testosterone plasma concentration–time profile Fig. 2 Mean free testosterone plasma concentration–time profile Fig. 3 Mean dihydrotestosterone plasma concentration–time profiles 3.1.2 Buspirone
and 1-(2-Pyrimidinyl)-Piperazine Pharmacokinetic results of the two administrations show that from both products, buspirone was absorbed with a T max between 3.69 and 3.95 hours and a half-life between 6.03 and 7.12 hours. Buspirone Tlag (median) was approximately 3 hours after F1 and approximately 3 hours and 20 minutes after F2 administration. Since for F1 the encapsulated tablet was taken after 150 minutes (2.5 h), the in vivo dissolution and absorption of buspirone took 30 minutes. The in vivo lag time for F2 was 200 – 30 = 170 minutes, which was well in line with in vitro observations of the tablet. 1-(2-pyrimidinyl)-piperazine reached the maximum concentration after approximately 4 hours (4.02–4.40 h) with a half-life between 4.84 and 4.86 hours.
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