Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition

Healthy Subjects Clinical Trial

Official title:

A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Fluoxetine From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05532332
• Other study ID #: ALZ-B-20-023
• Status: Completed
• Phase: Phase 1
• Start date: January 18, 2021
• Est. completion date: February 11, 2021

Study information

• Verified date: September 2022
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Fluoxetine 10 mg capsules
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
• Prozac® 10 mg capsules
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

Locations

Country	Name	City	State
Egypt	Future Research Center (FRC)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)	Cmax is observed as the maximum of Fluoxetine peak concentration	(Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
Primary	Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)	The AUC (0-72h) is the area under the Fluoxetine plasma concentration with time curve from the time of dosing to the 72-hour sample	(Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
Secondary	Maximum time (Tmax)	Time until Cmax is reached	(Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours