Bioequivalence Study of Aripiprazole in Healthy Adult Subjects Under Fasting Condition
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT05532254
- Lead Sponsor
- Future University in Egypt
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 31
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Reference Product (R) Abilify® 10 mg tablet subjects were administered a single tablet of 10 mg Aripiprazole with approximately 240 ml water after an overnight fast of 10 hours Test Product (T) Aripiprazole 10 mg tablet subjects were administered a single tablet of 10 mg Aripiprazole with approximately 240 ml water after an overnight fast of 10 hours
- Primary Outcome Measures
Name Time Method Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h) Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48, 72 hours post dose The AUC (0-72h) is the area under the Aripiprazole plasma concentration with time curve from the time of dosing to the 72-hour sample
Maximum plasma concentration (Cmax) Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48, 72 hours post dose Cmax is observed as the maximum of Aripiprazole peak concentration
- Secondary Outcome Measures
Name Time Method Maximum time (Tmax) Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48, 72 hours post dose Time until Cmax is reached
Trial Locations
- Locations (1)
Future Research Center (FRC)
🇪🇬Cairo, Egypt