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Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition

NCT05532332 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-09-08

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Fluoxetine 10 mg capsules

an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

DRUG

Prozac® 10 mg capsules

an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Principal Investigators

  • Hala Masoud, PhD · Future Research Center (FRC)

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-02-11
Completion
2021-02-11

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532332 on ClinicalTrials.gov