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CompletedNCT05804721Updated Apr 7, 2023

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)

A Phase 1 interventional study of Apipe (Aripiprazole10 mg) and Abilify (Aripiprazole10 mg) in Healthy, sponsored by Genuine Research Center, Egypt. Completed at 1 site in Egypt. Open to male participants aged 45 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Genuine Research Center, Egypt · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2022, registered Mar 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
Male
01

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

Read the 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%.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Genuine Research Center, Egypt is the lead sponsor of 36 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • DrugApipe (Aripiprazole10 mg)

    Test drug

    Also known as: Abilify

  • DrugAbilify (Aripiprazole10 mg)

    Reference drug

    Also known as: Abilify

06

What researchers measure

Primary outcomes

  1. Cmax

    to measure the maximal measured plasma concentration

    Time frame: Up to 72 hours post dose in each treatment period

Secondary outcomes

  1. Tmax

    time of the maximum plasma concentration

    Time frame: Up to 72 hours post dose in each treatment period

07

Study locations

1 site
  • Genuine Research Center GRC
    Cairo, 11757, Egypt
08

References and documents

Publications

  • 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. PubMed 11381568 ↗
  • 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. PubMed 3450848 ↗
  • 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. PubMed 2004861 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05804721
Lead sponsor
Genuine Research Center, Egypt
Collaborators
P&C Labs, Egypt
Responsible party
Sponsor
First posted
Apr 7, 2023
Start date
Oct 10, 2022
Primary completion
Nov 7, 2022
Completion
Dec 19, 2022
Last update
Apr 7, 2023

Study contacts

Ahmed Elshafeey, Ph.D. Pharma
study director · Genuine Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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