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)

Comparative Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence 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)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Apipe (Aripiprazole10 mg); Drug: Abilify (Aripiprazole10 mg)

Detailed Description

Healthy male volunteers, 45-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 24 subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report 18 blood samples will be drawn in each period. The total volume of blood will not exceed 200 ml throughout the whole study. 0.00, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours.

Primary Pharmacokinetic Parameters: Cmax, Truncated AUC0→72 Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax and Truncated AUC0→72 for untransformed data of Ke, tmax and t1/2e.

The confidence intervals of logarithmically transformed Test/Reference ratios for Truncated AUC0→72 and Cmax to be within 80.00-125.00%.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11757
    • Genuine Research Center GRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Females
2. Subjects with a prior personal or family history of dystonic reactions to medications.
3. Subjects with known allergy or any contraindications to the products tested.
4. Heavy smokers (more than 10 cigarettes per day).
5. 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
6. Subjects whose values of BMI were outside the accepted normal ranges.
7. Medical demographics with evidence of clinically significant deviation from normal medical condition.
8. Results of laboratory tests which are clinically significant.
9. Acute infection within one week preceding first study drug administration.
10. History of drug or alcohol abuse.
11. 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.
12. Subject is on a special diet (for example subject is vegetarian).
13. 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.
14. 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.
15. Subject has a history of severe diseases which have direct impact on the study.
16. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
17. Subject intends to be hospitalized within 3 months after first study drug administration.
18. Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T test; 1 orally disintegrating tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water	Drug: Apipe (Aripiprazole10 mg); Test drug; Other Names: Abilify
Active Comparator: R Reference; 1 orodispersible tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water	Drug: Abilify (Aripiprazole10 mg); Reference drug; Other Names: Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	to measure the maximal measured plasma concentration	Up to 72 hours post dose in each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	time of the maximum plasma concentration	Up to 72 hours post dose in each treatment period

Collaborators and Investigators

• Sponsor: Genuine Research Center, Egypt
• Collaborators: P&C Labs, Egypt

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101.
• 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.

Helpful Links

• Note for Guidance on Clinical Safety Data Management; Definitions And Standards for Expedited Reporting (CPMP/ICH/377/95) The European Agency for the Evaluation of Medicinal Products (EMEA) June 1995.
• Description: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The European Agency for the Evaluation of Medicinal Products (EMEA) May 1997

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: GRC/1/22/1016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No