Status:
COMPLETED
Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- Sex: Male and Female; similar proportion of each preferred.
- Age: At least 18 years.
- 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.
- Subjects must read and sign the Consent Form.
Exclusion
- Subjects not complying with the above inclusion criteria must be excluded from the study.
- 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.
- 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
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
- Subjects who have donated blood within four (4) weeks prior to the Initial dosing for this study.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00778024
Start Date
August 1 2003
End Date
December 1 2003
Last Update
December 15 2009
Active Locations (1)
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1
Gateway medical research
Saint Charles, Missouri, United States, 63301