NCT04650542

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

Open-Label, Two-Period Phase 1 Study in Healthy Subjects to Evaluate the Potential Effect of Multiple Doses of Paroxetine on the Pharmacokinetics and Safety of HBI-3000

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: HUYABIO International, LLC. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

Detailed description

This is a Phase 1 study in healthy volunteers to evaluate the potential effect of multiple doses of paroxetine on the pharmacokinetics and safety of HBI-3000. Each subject serves as his/her own control: Period 1 vs. Period 2.

Conditions

• Drug-drug Interaction

Interventions

Type	Name	Description
DRUG	HBI-3000	small molecule, multi-ion channel blocker
DRUG	Paroxetine	serotonin uptake inhibitor, CYP2D6 inhibitor

Timeline

• Start date: 2021-02-21
• Primary completion: 2021-08-13
• Completion: 2021-08-13
• First posted: 2020-12-02
• Last updated: 2022-07-15

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study