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NCT07121868: BEVocCapATCO

Bioequivalence Assessment Between Two Cariprazine Hard Capsule Formulations

Completed Phase 1 Last updated 17 August 2025
What this trial tests

Phase 1 trial testing Test Product (Vocarzine) in Bioequivalence Study in Healthy Subjects in 29 participants. Completed in 23 January 2025.

Timeline
3 August 2024
Primary endpoint
23 January 2025
23 January 2025

Quick facts

Lead sponsorAya Mohammed Abdel Magid Abdel Hamid
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment29
Start date3 August 2024
Primary completion23 January 2025
Estimated completion23 January 2025
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Aya Mohammed Abdel Magid Abdel Hamid — full company profile →

Who can join

Adults 18 to 55, any sex, with Bioequivalence Study in Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Bioequivalence evaluation of two cariprazine hard capsule formulations.
    Rezk MR, Badr KA, Hosny AAEH, Abdel Magid AM. · · 2026 · PMID 41689599 · DOI 10.1007/s00210-026-05017-1

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