the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
NCT Number: NCT05942365
This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Guangzhou, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug Warfarin oral Drug midazolam oral
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
Time frame: Day1 to Day28
To assess the safety and tolerability of ZSP1273 following single and multiple-dose administration with and without midazolamin+S-warfarin in healthy participates
Guangdong Raynovent Biotech Co., Ltd
Industry
A Phase 1, Open-Label, Two-Period,Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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