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A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects

NCT04291846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-07-27

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR1459 tablets.

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

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

SHR1459 fasted in P1, high-fat diet in P2

SHR1459 administration in fasted condition in period 1, SHR1459 administration after high-fat diet in period 2

DRUG

SHR1459 high-fat diet in P1, fasted in P2

SHR1459 administration after high-fat diet in period 1, SHR1459 administration in fasted condition in period 2

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Juan Li, M.D., Ph.D. · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-24
Primary Completion
2020-06-03
Completion
2020-06-29

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 NCT04291846 on ClinicalTrials.gov