NCT06057103

A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects

A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects -a Single-center, Open-labelled, Six-sequence, Three-cycle Crossover Design

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

Summary

The primary object of this study is evaluating the effect of multiple oral oseltamivir phosphate capsules on the pharmacokinetic profile of the active metabolite ZX-7101 after a single oral administration of ZX-7101A tablet in healthy Chinese adult subjects. The seongdary object is evaluating combined or uncombined multiple oral oseltamivir phosphate in healthy Chinese adult subjects.

Conditions

• Drug Interaction

Interventions

Type	Name	Description
DRUG	ZX-7101A	ZX-7101A Tablets single dose tablet, 80 mg, Oral
DRUG	Oseltamivir	Oseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral
DRUG	ZX-7101A and Oseltamivir	ZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral
DRUG	ZX-7101A	ZX-7101A Tablets single dose tablet, 80 mg, Oral
DRUG	Oseltamivir	Oseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral
DRUG	ZX-7101A and Oseltamivir	ZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral
DRUG	ZX-7101A	ZX-7101A Tablets single dose tablet, 80 mg, Oral

Timeline

• Start date: 2023-08-28
• Primary completion: 2023-12-05
• Completion: 2024-04-26
• First posted: 2023-09-28
• Last updated: 2024-11-04

Locations

1 site across 1 country: China