Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions

The Objective of This Randomized, Single-dose, Two-way Evaluation is to Compare the Bioequivalence of a Test Fluoxetine HCL Formulation (Ranbaxy Laboratories Limited, Lot No. 6320101) to an Equivalent Oral Dose of the Commercially Available Fluoxetine HCL (Prozac®, Dista Products Company, Lot No 6RK57M) in a Test Population of 36 Adult Subjects Under Fasting Conditions.

The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects under fasting conditions

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: fluoxetine HCL 40 mg capsules

Detailed Description

This is a single-dose, open-label, randomized two-way crossover study to evaluate the bioequivalence of a test formulation, versus an equivalent dose of a commercially available reference drug product, in 36 adult subjects, under fasted conditions. Drug administrations are separated by at least 49 days.

Vital signs (sitting blood pressure and pulse rate) were obtained at baseline (Hour 0), and at post-dose Hours 3, 8, 12, 24, 48, 72, 360, and 1056.

Of the 36 subjects enrolled into the study, 31 subjects completed the study in its entirety. Five (5) subjects were dropped out from the study.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Gateway Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Sex: Male and Female; similar proportion of each preferred.
2. Age: At least 18 years.

3. Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:

   • Laboratory Tests: Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, CL), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and urine pregnancy test prior to each study period at check-in. Laboratory values which are greater than :E20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.

   • Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.

4. Subjects must read and sign the Consent Form.

Exclusion Criteria:

1. Subjects not complying with the above inclusion criteria must be excluded from the study.

2. In addition, any one of the conditions listed below will exclude a subject from the study:

   • History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
   • History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
   • History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
   • History of treatment for astlzurta within the past five (5) years.
   • History of neurological impairment.
   • History of seizures.
   • History of Parkinson's Disease.
   • History of diabetes mellitus.
   • Females who are pregnant or lactating.
   • History of hypersensitivity to fluoxetine HCL, or any serotonin reuptake inhibitor.

3. Conditions upon screening which might contraindicate or require that caution be used in the administration of fluoxetlne HCL, including:

   • Sitting systolic blood pressure below 90 mm Hg, or diastolic Pressure below 50 mm Hg.
   • Heart rate less than 50 beats per minute after a 5-minute rest
4. Inability to read and/or sign the consent form.
5. Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
6. Subjects who have donated blood within four (4) weeks prior to the Initial dosing for this study.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; fluoxetine HCL 40 mg capsules of ranbaxy	Drug: fluoxetine HCL 40 mg capsules
Active Comparator: 2; PROZAC® 40 mg capsules	Drug: fluoxetine HCL 40 mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

• Sponsor: Ranbaxy Laboratories Limited

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): December 1, 2003

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 22, 2008
• First Posted (Estimate): October 23, 2008

Study Record Updates

• Last Update Posted (Estimate): December 15, 2009
• Last Update Submitted That Met QC Criteria: December 11, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence fluoxetine HCL 40 mg capsules fasting conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: 03197