Table 6 Summary of pharmacokinetic parameters for S-Adenosylmethionine oral dosage forms for single dosing in Stages 1 and 2. Values are presented as the mean with the standard deviation (SD)
Treatment | ||||||
MSI-195 400 mg | MSI-195 800 mg | MSI-195 1600 mg | ||||
Study Stage 1 | ||||||
Variable | Mean | SD | Mean | SD | Mean | SD |
Cmax, ng/mLa | 1045.4 | 601.8 | 3255.5 | 2347.1 | 4808.8 | 4028.2 |
Tmax, h | 7.75 | 9.12 | 3.00 | 2.90 | 3.25 | 7.81 |
AUCT, ng h/mL | 4643.9 | 2519.2 | 9360.6 | 5338.9 | 16,511.0 | 10,736.0 |
AUC∞, ng h/mLb | 5322.1 | 956.1 | 10,633.2 | 5147.3 | 16,454.2 | 10,675.7 |
Kel, h−1 | 0.0465 | 0.01 | 0.0886 | 0.04 | 0.1056 | 0.05 |
T1/2, h | 16.01 | 4.90 | 8.87 | 3.08 | 7.77 | 3.26 |
Study Stage 2 | ||||||
MSI-195 800 mg Fasted | MSI-195 800 mg Fed | SAMe 1600 mg Fasted | ||||
Variable | Mean | SD | Mean | SD | Mean | SD |
Cmax, ng/mL | 3280.8 | 2383.8 | 1461.0 | 1153.7 | 1984.3 | 1430.0 |
Tmax, h | 4.50 | 1.72 | 13.00 | 6.03 | 6.00 | 1.23 |
AUCT, ng h/mL | 9434.4 | 5196.1 | 5224.7 | 3094.6 | 6643.8 | 3326.4 |
AUC∞, ng h/mL | 10,025.5 | 4799.5 | 7445.4 | 2688.2 | 7144.4 | 3214.2 |
Kel, h−1 | 0.1007 | 0.08 | 0.2322 | 0.07 | 0.0926 | 0.04 |
T1/2, h | 11.47 | 7.66 | 3.30 | 1.37 | 9.27 | 4.59 |