A Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects

NCT05049083 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-01-14

No results posted yet for this study

Summary

TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects.

Conditions

Interventions

DRUG

New Process SHR2554 tablet、Former Process SHR2554 tablet

New Process, 350 mg SHR2554 tablets on study day 1 - Former Process, 350 mg SHR2554 tablets on study day 8

DRUG

Former Process SHR2554 tablet、New Process SHR2554 tablet

Former Process, 350 mg SHR2554 tablets on study day 1 - New Process, 350 mg SHR2554 tablets on study day 8

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2022-01-06
Completion
2022-04-29

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 NCT05049083 on ClinicalTrials.gov