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Clinical Trial Summary

This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of [14C]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.


Clinical Trial Description

This study will evaluate the mass balance and pharmacokinetics of DBPR108 in approximately 6 healthy male subjects receiving a single oral 100 mg dose of DBPR108 containing approximately 150 µCi of [14C]- DBPR108. This study consists of a screening period (Day -7 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05072028
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date October 2021
Completion date March 2022

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