Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-27 @ 12:53 PM
Study NCT ID:
NCT05532332
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2022-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition
Sponsor:
Future University in Egypt
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: