NCT05504876

Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose of HEC74647 and HEC110114 on the Pharmacokinetics of Midazolam, and Their Metabolites in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label study to investigate whether HEC74647 and HEC110114 has an effect on the pharmacokinetic (PK) profile of midazolam（a cytochrome (CYP) 3A4 substrate）in healthy subjects

Detailed description

This is a single center, open-label study in healthy adult subjects. Total 14 subjects will be enrolled into the study and will be receive study drug per the defined treatment.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Midazolam Syrup	Administered Midazolam Syrup 5 mg orally once daily in fed state;
DRUG	HEC74647PA	Administered HEC74647PA 100 mg orally once daily in fed state;
DRUG	HEC110114	Administered HEC110114 600 mg orally once daily in fed state;

Timeline

• Start date: 2022-11-07
• Primary completion: 2022-12-13
• Completion: 2022-12-13
• First posted: 2022-08-17
• Last updated: 2022-12-21

Locations

1 site across 1 country: China