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A Drug Interaction Study of SY-004 Capsules in Healthy Subjects

NCT04907019 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-05-18

No results posted yet for this study

Summary

A single center, open-label, single sequence study was conducted to evaluate the potential drug interaction of CYP3A4 inducer rifampicin with SY-004 capsules in healthy subjects

Conditions

Interventions

DRUG

rifampicin，SY-004

On the morning of D1, the subjects will take orally 80 mg of SY-004 Capsules on an empty stomach.Fasting will be performed within 4 hours after taking the medicine. From D8 to D14, the subjects will take orally 600 mg rifampicin before breakfast every day. On the day of D15, the subjects will take orally 600 mg rifampicin and 80 mg SY-004 Capsules on an empty stomach. From D16 to D21, subjects will take orally 600 mg of rifampicin before breakfast every day.The patient can be discharged from the hospital after completing the safety examination on D22.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2021-08-17
Completion
2021-08-17

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 NCT04907019 on ClinicalTrials.gov