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drugset / Trial / NCT05949385

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

NCT05949385 ↗

Phase 1 Completed 16 enrolled Nanjing Zenshine Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg Oral
Subject ZX-7101A Unknown 40 mg Oral

Indications

No indication recorded.