NCT04907019

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

A Single Center, Open-label, Single Sequence Study to Evaluate the Potential Drug Interaction of CYP3A4 Inducer Rifampicin With SY-004 Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Type 2 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-06
• Primary completion: 2021-08-17
• Completion: 2021-08-17
• First posted: 2021-05-28
• Last updated: 2022-05-18

Locations

1 site across 1 country: China