A Phase 1 interventional study of Fluoxetine 10 mg capsules and Prozac® 10 mg capsules in Healthy Subjects, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.
Sponsored by Future University in Egypt · Phase 1, Interventional, and Health services research
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.
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.
Future University in Egypt is the lead sponsor of 97 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
Also known as: Test product (T)
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
Also known as: Reference product (R)
Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Fluoxetine peak concentration
Time frame: (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
Time frame: (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
Maximum time (Tmax)
Time until Cmax is reached
Time frame: (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
Plan to share: Yes — Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Future University in Egypt