A Bioequivalence Trial of Fasting Single Oral STI-1558 Capsule in Healthy Chinese Subjects
Status:
Completed
Trial end date:
2023-11-08
Target enrollment:
Participant gender:
Summary
This study is a randomized, open, single-dose, two-sequence, two-cycle, double-cross design
bioequivalence study.
32 eligible subjects will be randomly assigned to TR group and RT group in a 1:1 ratio.
Subjects in the TR group will take the test preparation (T) 200 mg/ pill × 1 pill on day 1
(D1) and the reference preparation (R) 200 mg/ pill × 1 pill on day 8 (D8). The sequence of
medication in RT group is reversed from TR group. Wash for at least 7 days between doses.
Screening was performed within 28 days prior to initial dosing, and all eligible subjects
were admitted to the clinical research Center 1 day prior to Cycle 1 dosing (D-1) and
discharged on day 10 of the study (D10) after completing Cycle 2 PK blood collection,
corresponding safety examination, and evaluation. On the 14th day of the study (± 1 day), the
clinical research center was returned for follow-up to further evaluate the safety and
tolerability of the subjects.