MedDataX Logo

To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions

NCT ID: NCT00913718

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-06-30

Study Completion Date

1996-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions

NCT00913588

Depression
COMPLETED PHASE1

To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg

NCT00947076

Depression
COMPLETED PHASE1

90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions

NCT01247272

Healthy
COMPLETED PHASE1

90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

NCT01247285

Healthy
COMPLETED PHASE1

A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria

NCT00516113

Premenstrual Dysphoric Disorder Premenstrual Syndrome
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)

Group Type EXPERIMENTAL

Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)

Intervention Type DRUG

2

Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)

Group Type ACTIVE_COMPARATOR

Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)

Intervention Type DRUG

Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sandoz Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roderick Malone, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center (Cincinnati)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

960380

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prozac Treatment of Major Depression: Discontinuation Study
NCT00427128 COMPLETED PHASE4
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
NCT01235195 COMPLETED PHASE1
A Study of RO4917523 in Patients With Treatment Resistant Depression
NCT00809562 COMPLETED PHASE2
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder
NCT00057213 COMPLETED PHASE2
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions
NCT00883155 COMPLETED PHASE1
An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder
NCT00057239 COMPLETED PHASE2
Food and Relative Bioavailability Study
NCT00843011 COMPLETED PHASE1
Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions
NCT04723238 COMPLETED PHASE1
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets
NCT00913237 COMPLETED PHASE1
Study of Rapastinel as Monotherapy in Patients With MDD
NCT03560518 TERMINATED PHASE3
Drug Use Investigation for PAXIL Tablet
NCT01371435 COMPLETED
Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects
NCT01318031 COMPLETED PHASE1
Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®
NCT03357796 COMPLETED PHASE1
Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
NCT02366364 COMPLETED PHASE1
MDD POC Study GSK372475 Subjects Depressive Disease
NCT00420641 COMPLETED PHASE2
An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder
NCT00057226 COMPLETED PHASE2
Study in Major Depressive Disorder With NMRA-335140 (BTRX-335140) vs Placebo
NCT04221230 COMPLETED PHASE2
To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions
NCT00861939 COMPLETED PHASE1
Comparison of Orcinoside With Placebo in Treatment of MDD
NCT02191384 COMPLETED PHASE2
Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
NCT01371461 COMPLETED
OSU6162 as add-on in SSRI/SNRI-resistant Depression
NCT05641623 RECRUITING PHASE2
Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
NCT03551288 COMPLETED PHASE1
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
NCT03352453 TERMINATED PHASE2
A Multiple Ascending Oral Dose Evaluation of the Safety, Tolerability, and Pharmacokinetics of DSP-1053 and Its Metabolites in Healthy Subjects and in Subjects With Major Depressive Disorder
NCT01774747 TERMINATED PHASE1
Efficacy Study of RX-10100 to Treat Major Depressive Disorder (MDD)
NCT00839176 COMPLETED PHASE2