NCT05586568

Drug-drug Interaction Study of XZP-3621 Tablet

A Drug-drug Interaction Study Evaluating the Pharmacokinetic Effects of Itraconazole or Rifampin or Esomeprazole on XZP-3621 Tablets in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single center, 2 period, one sequence study to investigate the potential drug drug interaction between itraconazole or rifampin or esomeprazole and XZP-3621 tablet.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	XZP-3621 tablet and itraconazole oral liquid (for Arm1)	There are 2 periods, for the 1st period, the subjects will only take XZP-3621 tablets QD on Day1. For period 2,the subjects will take itraconazole from Day11 to Day13，they will take itraconazole in combinaiton with XZP-3621 on Day14，then take itraconazole only, from Day15 to Day27.
DRUG	XZP-3621 tablet and Rifampicin capsules (For Arm 2)	There are 2 periods, for the 1st period, the subjects will only take XZP-3621 tablets qd on Day1 . For period 2,the subjects will take Rifampicin from Day11 to Day17，they will take Rifampicin in combinaiton with XZP-3621 on day18，then take Rifampicin only, from Day19 to Day26.
DRUG	XZP-3621 tablet and esomeprazole tablet (For Arm3)	There are 2 periods, for the 1st period, the subjects will only take XZP-3621 tablets QD on Day1 . For period 2,the subjects will take esomeprazole from Day11 to Day 15，they will take esomeprazole in combinaiton with XZP-3621 on Day16.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-04-05
• Completion: 2023-08-02
• First posted: 2022-10-19
• Last updated: 2022-10-19

Locations

1 site across 1 country: China