NCT04907006

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

A Randomized, Open-label, Two-period, Double Crossover, Single Center Study to Evaluate the Effect of High-fat Diet on the Pharmacokinetics of SY-004 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 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

Detailed description

This study will evaluate the effect of high-fat diet on the pharmacokinetics of SY-004.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-31
• Primary completion: 2021-10-11
• Completion: 2021-10-11
• First posted: 2021-05-28
• Last updated: 2022-05-18

Locations

1 site across 1 country: China