NCT05949385

A Study to Assess the Effect of Itraconazole Capsules on the Pharmacokinetics of ZX-7101A Tablets in Healthy Adult Subjects in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the effect of Itraconazole on pharmacokinetics of ZX-7101 in healthy Chinese adult subjects after oral administration of ZX-7101A tablets. The secondary objective of the study is to evaluate the safety and tolerability of single dose of ZX-7101A orally in healthy subjects. Evaluate the effect of Itraconazole on pharmacokinetics of pre-drug ZX-7101A in healthy Chinese adult subjects after oral administration of ZX-7101A tablets.

Detailed description

ZX-7101A tablets 40 mg once on Day 1 and Day 31, Itraconazole 200 mg once daily (QD) from Study Day 26 - 50

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	ZX-7101A	Single dose of oral administration of ZX-7101A and Multiple dose of oral of Itraconazole Capsules

Timeline

• Start date: 2023-07-02
• Primary completion: 2023-09-23
• Completion: 2024-01-11
• First posted: 2023-07-18
• Last updated: 2024-11-05

Locations

1 site across 1 country: China