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Drug-drug Interaction Study of XZP-3621 Tablet

NCT05586568 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-10-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Xuanzhu Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yu Cao · The Affiliated Hospital of Qingdao University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2023-04-05
Completion
2023-08-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586568 on ClinicalTrials.gov