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A Food-drug Interaction Study of SY-004 in Healthy Subjects

NCT04907006 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-05-18

No results posted yet for this study

Summary

A randomized, open, two cycle, double crossover, single center study was conducted to evaluate the effect of high-fat diet on the pharmacokinetics of SY-004 in healthy subjects

Conditions

Interventions

DRUG

SY-004 capsule

After fasting for 10 hours, subjects in group 1 took one SY-004 (80mg) orally on an empty stomach on the day of administration with 240ml warm water; Subjects in group 2 began to eat high-fat breakfast 30 minutes before administration , and took one SY-004 capsule（80mg） orally with 240ml warm water. The subjects in both groups were fasted within 4 hours after taking the medicine, and drinking water was forbidden within 1 hour before and after taking SY-004.

Sponsors & Collaborators

  • Suzhou Yabao Pharmaceutical R&D Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Haitang Xie, Dr · Wannan Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2021-10-11
Completion
2021-10-11

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 NCT04907006 on ClinicalTrials.gov