Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition

NCT ID: NCT05532332

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2021-02-11

Brief Summary

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each Fluoxetine 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.

Fluoxetine plasma concentrations were determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Test Product (T)

subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours

Group Type: EXPERIMENTAL

Fluoxetine 10 mg capsules

Intervention Type: DRUG

an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

Reference Product (R)

subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours

Group Type: ACTIVE_COMPARATOR

Prozac® 10 mg capsules

Intervention Type: DRUG

an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

Interventions

Fluoxetine 10 mg capsules

an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

Intervention Type: DRUG

Prozac® 10 mg capsules

an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

Intervention Type: DRUG

Other Intervention Names

Test product (T); Reference product (R)

Eligibility Criteria

Inclusion Criteria

• Written informed consent is obtained for the study.
• Age 18 - 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 any 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 of 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Hala Masoud

FRC Technical Director & CEO

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Masoud, PhD

Role: PRINCIPAL_INVESTIGATOR

Future Research Center (FRC)

Locations

Future Research Center (FRC)

Cairo, , Egypt

Countries

Egypt

Other Identifiers

ALZ-B-20-023

Identifier Type: -

Identifier Source: org_study_id