drugset / Trial / NCT05034120

Food Effect and Mass Balance Study of XZP-3621 Tablets

NCT05034120

Phase 1 Completed 34 enrolled Xuanzhu Biopharmaceutical Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects. The stage 2 is to evaluate the effect of food on the Pharmacokinetics of single-dose XZP-3621 tablets in Chinese Healthy Volunteers. In addition, the safety of XZP-3621 tablets in Chinese Healthy Volunteers will also be evaluated.

Timeline

Start
2021-12-23
Primary completion
2022-03-30
Completion
2022-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject XZP-3621 Unknown 400 mg Oral

Indications

No indication recorded.