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Bioequivalence Study of Aripiprazole in Healthy Adult Subjects Under Fasting Condition

NCT05532254 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-09-08

No results posted yet for this study

Summary

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Aripiprazole 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.

Conditions

  • Healthy Subjects

Interventions

DRUG

Aripiprazole 10 mg tablet

an immediate-release tablet containing 10 mg Aripiprazole

DRUG

Abilify® 10 mg tablet

an immediate-release tablet containing 10 mg Aripiprazole

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Principal Investigators

  • Hala Masoud, PhD · Future Research Center (FRC)

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-14
Primary Completion
2021-03-11
Completion
2021-03-11

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532254 on ClinicalTrials.gov