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

NCT06044233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

STI-1558

STI-1558 test preparation and reference preparation

Sponsors & Collaborators

  • Zhejiang ACEA Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen Jian, master · Zhejiang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2023-10-23
Completion
2023-11-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06044233 on ClinicalTrials.gov