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A Study to Assess the Effect of Itraconazole Capsules on the Pharmacokinetics of ZX-7101A Tablets in Healthy Adult Subjects in China

NCT05949385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-05

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the effect of Itraconazole on pharmacokinetics of ZX-7101 in healthy Chinese adult subjects after oral administration of ZX-7101A tablets.

The secondary objective of the study is to evaluate the safety and tolerability of single dose of ZX-7101A orally in healthy subjects.

Evaluate the effect of Itraconazole on pharmacokinetics of pre-drug ZX-7101A in healthy Chinese adult subjects after oral administration of ZX-7101A tablets.

Conditions

  • Pharmacokinetics

Interventions

DRUG

ZX-7101A

Single dose of oral administration of ZX-7101A and Multiple dose of oral of Itraconazole Capsules

Sponsors & Collaborators

  • Nanjing Zenshine Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-07-02
Primary Completion
2023-09-23
Completion
2024-01-11

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 NCT05949385 on ClinicalTrials.gov