Bioequivalence Study of Aripiprazole in Healthy Adult Subjects Under Fasting Condition

F

Future University in Egypt

Status and phase

Completed
Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Aripiprazole 10 mg tablet
Drug: Abilify® 10 mg tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05532254
ARI-B-20-031

Details and patient eligibility

About

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Aripiprazole 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.

Full description

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days. Aripiprazole plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Enrollment

31 patients

Sex

Male

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Written informed consent is obtained for the study.
  • Age 35 - 55 years
  • Body mass index between 18.5 and 30 kg/m2
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
  • Vital signs without significant deviations.
  • All laboratory screening results are within the normal range or clinically non-significant

Exclusion criteria

  • History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the investigator's opinion.
  • History of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
  • Any confirmed significant allergic reactions against any drug or multiple allergies.
  • Clinically significant illness 28 days before study phase I.
  • Alcohol or any solvent intake.
  • Regular use of medication.
  • Positive urine screening of drugs of abuse.
  • Use any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
  • History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
  • Blood donation within the past 60 days.
  • Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Test Product (T)
Experimental group
Description:
subjects were administered a single tablet of 10 mg Aripiprazole with approximately 240 ml water after an overnight fast of 10 hours
Treatment:
Drug: Aripiprazole 10 mg tablet
Reference Product (R)
Active Comparator group
Description:
subjects were administered a single tablet of 10 mg Aripiprazole with approximately 240 ml water after an overnight fast of 10 hours
Treatment:
Drug: Abilify® 10 mg tablet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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