Healthy Subjects
Conditions
Keywords
Bioequivalence, Randomized, Crossover, Fluoxetine
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.
Interventions
DRUGFluoxetine 10 mg capsules
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
DRUGProzac® 10 mg capsules
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | (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 | Cmax is observed as the maximum of Fluoxetine peak concentration |
| Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h) | (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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum time (Tmax) | (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 | Time until Cmax is reached |
Countries
Egypt
Outcome results
None listed