NCT06841926

Study to Evaluate the Pharmacokinetics and Relative Bioavailability of Metabolites in Healthy Chinese Adult Males

A Study to Evaluate the Pharmacokinetics of ZX-7101A for Suspension Versus Tablets in a Single Oral Administration Under Fasting Conditions in Healthy Chinese Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study to evaluate the pharmacokinetics and relative bioavailability of metabolites in healthy Chinese adult males

Detailed description

To evaluate the pharmacokinetic profile and relative bioavailability of the active metabolite ZX-7101 (parent drug) after a single oral administration of 40 mg ZX-7101A for suspension and 40 mg ZX-7101A tablet in healthy Chinese adult male subjects

Conditions

• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	ZX-7101A dry suspension	Test formulation (T) : ZX-7101A dry suspension Specification: 10 mg/ bag Dosage：40 mg (4 bags)、 once
OTHER	ZX-7101A tablet	Reference formulation (R): ZX-7101A tablet Specification: 40 mg/ tablet Dosage：40 mg (1 tablet)、 once

Timeline

• Start date: 2025-02-20
• Primary completion: 2025-04-18
• Completion: 2025-04-18
• First posted: 2025-02-24
• Last updated: 2025-05-11

Locations

1 site across 1 country: China