NCT04951713

Effect of Clarithromycin and Rifampicin on the Pharmacokinetics of XZP-3287 in Healthy Subjects

A Single-center, Open-label, Drug-drug Interaction Study of XZP-3287 Tablets in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase I study to assess the drug-drug interaction of XZP-3287 and Clarithromycin/Rifampicin. The study also evaluates the pharmacokinetic and tolerability of XZP-3287 in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	XZP-3287 combined with clarithromycin	Drug: XZP-3287, oral, 120 mg once daily for day 1 and day 12 Drug: clarithromycin, oral, 500 mg twice daily for day 8 to day 21
DRUG	XZP-3287 combined with rifampicin	Drug: XZP-3287, oral, 360 mg once daily for day 1 and day 14 Drug: rifampicin, oral, 600 mg once daily for day 8 to day 19

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2021-07-07
• Last updated: 2021-07-27

Locations

1 site across 1 country: China