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Bioequivalence Assessment Between Two Cariprazine Hard Capsule Formulations

NCT07121868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-08-17

No results posted yet for this study

Summary

An open label, randomized, single-dose, two sequence, two-period, crossover study to assess the bioequivalence of Cariprazine in Vocarzine 1.5 mg hard gelatin capsule (Test product) in comparison with Reagila® 1.5 mg hard capsules (Reference product) in 30 healthy subjects under fasting conditions

Conditions

  • Bioequivalence Study in Healthy Subjects

Interventions

DRUG

Test Product (Vocarzine)

hard capsule formulation

DRUG

Reference (R) Reagila ®

hard capsule formulation

Sponsors & Collaborators

  • Advanced Research Center (ARC)

    collaborator UNKNOWN

  • Atco Pharma for Pharmaceutical Industries

    collaborator UNKNOWN

  • Aya Mohammed Abdel Magid Abdel Hamid

    lead OTHER

Principal Investigators

  • Kamal A. Badr, PhD · Advanced Research Center (ARC)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-03
Primary Completion
2025-01-23
Completion
2025-01-23

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 NCT07121868 on ClinicalTrials.gov