Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions
NCT ID: NCT00778024
Last Updated: 2009-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2003-08-31
2003-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
fluoxetine HCL 40 mg capsules of ranbaxy
fluoxetine HCL 40 mg capsules
2
PROZAC® 40 mg capsules
fluoxetine HCL 40 mg capsules
Interventions
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fluoxetine HCL 40 mg capsules
Eligibility Criteria
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Inclusion Criteria
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.
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.
18 Years
ALL
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Labs
Locations
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Gateway medical research
Saint Charles, Missouri, United States
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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03197
Identifier Type: -
Identifier Source: org_study_id