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A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers

NCT04395053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-11-07

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations.

The secondary objective of the study is to evaluate the safety after single dose of SHR1459 orally in healthy Chinese subjects.

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

SHR1459

TR group: The first period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h. RT group: The first period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h.

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
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-28
Primary Completion
2020-07-11
Completion
2020-08-01

Countries

  • China

Study Locations

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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 NCT04395053 on ClinicalTrials.gov