Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Fluoxetine 10 mg capsules
* Drug: Prozac® 10 mg capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product (T)<br>subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours | Drug: Fluoxetine 10 mg capsules<br>* an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg<br>* Other names: Test product (T);|
| Active Comparator: Reference Product (R)<br>subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours | Drug: Prozac® 10 mg capsules<br>* an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg<br>* Other names: Reference product (R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Randomized, Crossover, Fluoxetine