C_max, maximum plasma concentration; AUC_0-t, area under the concentration-time to the last quantifiable concentration; AUC_0-∞, area under the concentration-time to infinity; n, the number of subject enrolled in the PK parameters analysis set; GM, geometric mean; CI, coefficient of variation.

^aThe values after logarithm transformation used PROC MIXED process to carry out analysis of variance. Coadministration or not was introduced into the model as a fixed effect, and individuals were introduced into the model as random effects.

^b1 subject concealed the history of epilepsy and taking magnesium valproate for a long time, considering potential hepatotoxicity, he was excluded from the PK parameters set.

^c1 subject could not be enrolled in the analysis of PK parameters set mixed-effects model due to AUC_t-∞ >20%.

^d2 subjects could not be enrolled in the analysis of PK parameters set mixed-effects model due to AUC_t-∞>20%.

Table 4 Summary of treatment-emergent adverse events (TEAEs).

Ev (n), number of events; n (%), number of patients (percentage of the treatment group).

To analyze the association between the TEAEs and the study drug, three assessments were made: unrelated or unlikely, potentially, probably, or definitely related.