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Bioequivalence Study of Aripiprazole From Apipe 10 mg Orally Disintegrating Tablets (Man. by: P&C Labs (Pellets & CR Products), Egypt) Versus Abilify 10 mg Orodispersible Tablets (Otsuka Pharmaceutical Netherlands B.V., Netherlands)

NCT05804721 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-04-07

No results posted yet for this study

Summary

Comparative randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Aripiprazole from Apipe 10 mg orally disintegrating tablets (Man. by: P\&C Labs (Pellets\&CR Products), Egypt) versus Abilify 10 mg orodispersible tablets (Otsuka Pharmaceutical Netherlands B.V., Netherlands ) in Healthy Human Volunteers Under Fasting Condition

Conditions

  • Healthy

Interventions

DRUG

Apipe (Aripiprazole10 mg)

Test drug

DRUG

Abilify (Aripiprazole10 mg)

Reference drug

Sponsors & Collaborators

  • P&C Labs, Egypt

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2022-11-07
Completion
2022-12-19

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 NCT05804721 on ClinicalTrials.gov