NCT06044233

A Bioequivalence Trial of Fasting Single Oral STI-1558 Capsule in Healthy Chinese Subjects

A Randomized, Open, Two-sequence, Two-cycle, Double-cross Design Bioequivalence Trial of Fasting Single Oral STI-1558 Capsule in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The trial drug STI-1558 should be taken with approximately 240 ml of water after fasting overnight for at least 10h. Except for drinking water, water should be prohibited for at least 1h before and after administration, and fasting should be at least 4h after administration. Test drugs (T and R) must be swallowed whole and not chewed, crushed or separated. In order to ensure the subject's compliance with the medication procedure, the staff should check the subject's mouth after taking the medication. 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	STI-1558	STI-1558 test preparation and reference preparation

Timeline

• Start date: 2023-09-28
• Primary completion: 2023-10-23
• Completion: 2023-11-08
• First posted: 2023-09-21
• Last updated: 2023-12-13

Locations

1 site across 1 country: China