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A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects

NCT06325761 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-03-22

No results posted yet for this study

Summary

This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.

Conditions

  • Health Subjects

Interventions

DRUG

SY-5007

SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days

DRUG

SY-5007

SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days

Sponsors & Collaborators

  • Shouyao Holdings (Beijing) Co. LTD

    lead OTHER

Principal Investigators

  • Yinghui Sun, Dr · Shouyao Holdings (Beijing) Co. LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-05-01
Completion
2024-05-01

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 NCT06325761 on ClinicalTrials.gov