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NCT04650542 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by HUYABIO International.

Completed
Registry status
Phase 1
Development phase
39
Enrollment target

NCT04650542: Completed Phase 1 study, sponsored by HUYABIO International.

NCT04650542 is a Phase 1 study that has completed, run by HUYABIO International. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04650542, a Phase 1 study, has completed, sponsored by HUYABIO International.

COMPLETED
Registry status
Phase 1
Development phase
39 participants
Enrollment target

Study Summary

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

Primary Outcome

To determine the plasma Cmax of a single dose of HBI 3000 administered intravenously (IV), in the absence and the presence of CYP2D6 inhibition, achieved with multiple oral doses of paroxetine, a strong CYP2D6 inhibitor, in healthy male and female subjects. Blood samples will be taken from 0 through 72 hours after the start of HBI-3000 infusion.

Interventions

  • DRUG Paroxetine
  • DRUG HBI-3000

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2021-02-21
Est. Completion 2021-08-13
Phase Phase 1
HUYABIO International

7 total trials

What the finished NCT04650542 record still lists

NCT04650542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).

The record links to 0 conditions, and to 2 interventions - of which Paroxetine is the first listed.

NCT04650542 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04650542 about?

NCT04650542 is a clinical study titled "Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects". Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

What is the current status of trial NCT04650542?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2021-02-21. Estimated completion is 2021-08-13.

What interventions are being tested in trial NCT04650542?

The interventions under investigation include: Paroxetine (DRUG), HBI-3000 (DRUG).

Who is sponsoring clinical trial NCT04650542?

This trial is sponsored by HUYABIO International, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04650542's enrollment target sits among peer trials

39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04650542, the US trial registry maintained by the National Library of Medicine. NCT04650542 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.