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NCT04030143 · ClinicalTrials.gov registry record · Phase 1

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 1
Development phase
266
Enrollment target

NCT04030143 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 266 participants.

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The verdict

NCT04030143, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
266 participants
Enrollment target

Study Summary

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

Interventions

  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 266 participants
Start Date 2019-08-01
Est. Completion 2020-07-08
Phase Phase 1

What the Registry Record Tells You About NCT04030143

The ClinicalTrials.gov registry entry for NCT04030143 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.

NCT04030143 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04030143 about?

NCT04030143 is a clinical study titled "A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder". The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, a...

What is the current status of trial NCT04030143?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 266 participants. The study started on 2019-08-01. Estimated completion is 2020-07-08.

What interventions are being tested in trial NCT04030143?

The interventions under investigation include: Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT04030143?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.