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AzTrials

HealthyPhase 1NCT05804721

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 study testing Apipe (Aripiprazole10 mg) and Abilify (Aripiprazole10 mg) in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Apipe (Aripiprazole10 mg) and Abilify (Aripiprazole10 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteEgypt
Study dates
10 Oct 2022to 19 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
  • Subject intends to be hospitalized within 3 months after first study drug administration.
  • Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Genuine Research Center GRC

    Cairo, 11757

Other trials in Egypt

About this study

Official title: 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

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%.

Conditions
Healthy
Being tested
Apipe (Aripiprazole10 mg), Abilify (Aripiprazole10 mg)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apipe (Aripiprazole10 mg)Drug

    Also called Abilify

    Test drug

  • Abilify (Aripiprazole10 mg)Drug

    Also called Abilify

    Reference drug

Study groups in NCT05804721
Study groupRoleWhat they receive
T testExperimental1 orally disintegrating tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water
Receives: Drug: Apipe (Aripiprazole10 mg)
R ReferenceActive comparator1 orodispersible tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water
Receives: Drug: Abilify (Aripiprazole10 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    to measure the maximal measured plasma concentration

    Measured: Up to 72 hours post dose in each treatment period

Secondary outcomes (1)

  1. Tmax

    time of the maximum plasma concentration

    Measured: Up to 72 hours post dose in each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start10 Oct 2022
  3. Primary completion7 Nov 2022
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05804721
Sponsor's protocol ID
GRC/1/22/1016
Status last verified
Mar 2023
First submitted
27 Mar 2023
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apipe (Aripiprazole10 mg) and Abilify (Aripiprazole10 mg) in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Up to 72 hours post dose in each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05804721, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.

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