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 | Completed Phase 1

• 1 other identifier: GRC/1/22/1016
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cmax

  to measure the maximal measured plasma concentration

  Up to 72 hours post dose in each treatment period

Secondary Outcomes (1)

• Tmax

  Up to 72 hours post dose in each treatment period

Study Arms (2)

T test

EXPERIMENTAL

1 orally disintegrating tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water

Drug: Apipe (Aripiprazole10 mg)

R Reference

ACTIVE COMPARATOR

1 orodispersible tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water

Drug: Abilify (Aripiprazole10 mg)

Interventions

Apipe (Aripiprazole10 mg) DRUG

Test drug

Also known as: Abilify

T test

Abilify (Aripiprazole10 mg) DRUG

Reference drug

Also known as: Abilify

R Reference

Eligibility Criteria

• Age: 45 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male, age 45 to 55 years, inclusive.
• Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
• Medical demographics without evidence of clinically significant deviation from normal medical condition.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Fully informed subjects that consented to participate in the study.
• Subject does not have allergy to the drugs under investigation.

You may not qualify if:

• Females
• Subjects with a prior personal or family history of dystonic reactions to medications.
• Subjects with known allergy or any contraindications to the products tested.
• Heavy smokers (more than 10 cigarettes per day).
• Subjects that do not agree not to consume alcohol-containing beverages and foods for 48 hours before dosing and throughout the period of sample collection
• Subjects whose values of BMI were outside the accepted normal ranges.
• Medical demographics with evidence of clinically significant deviation from normal medical condition.
• Results of laboratory tests which are clinically significant.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
• Subject is on a special diet (for example subject is vegetarian).
• Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
• Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
• Subject has a history of severe diseases which have direct impact on the study.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• P&C Labs, Egypt: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.

  PMID: 11381568 BACKGROUND

• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

• Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.

  PMID: 2004861 BACKGROUND

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: October 10, 2022
• Primary Completion: November 7, 2022
• Study Completion: December 19, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)