Safety
Seventeen AEs occurred in eleven subjects in the fasting condition, and
the incidence rate of AEs was 27.50% (11/40); among them, six cases
(15.00%, 6/40) and 9 cases occurred in the test formulation, seven
subjects of eight cases (17.95%, 7/39) occurred in the reference
formulation. In addition, as for the fed condition, a total of sixteen
AEs occurred in thirteen subjects in the postprandial test in this
study, and the incidence rate of adverse events was 32.50% (13/40);
among them, eight cases (21.05%, 8/38) and nine cases occurred in the
test formulation, five cases (13.16%, 5/38) and seven cases occurred in
the reference formulation. The more common AEs in this trial included
rosacea, oral ulcers, urticaria, elevated glutathione and glutathione
transaminases, elevated bilirubin, and elevated uric acid. Collectively,
neither serious safety attentions nor unexpected Ars of the T or R
formulation was observed during this study.