Bioequivalence Study of Furosemide 80mg Tablets Under Fasting Conditions

Launched by RANBAXY LABORATORIES LIMITED · Oct 22, 2008

Keywords

ClinConnect Summary

This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 80 mg furosemide tablets under fasted conditions. The study was conducted with 44 (39 completing) healthy adults in accordance with protocol. In each study period, a single 80 mg dose was administered to the subjects following an overnight fast. The test formulation was furosemide 80 mg tablet (Ohm Laboratories, Inc.), and the reference formulation was Lasix® (furosemide) 80 mg tablet (Aventis Pharmaceuticals NJ). The subjects received the test product in one s...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • • Males and females aged 18 years of age or older with a body mass index (BMI) in the range 18-30 kg/m2 inclusive, measured according to Novum Standard Operating Procedures.
• • Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
• • Signed and dated informed consent form, which meets all criteria of current FDA regulations.
• • Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study. All females in the study will have pregnancy tests performed at screening at check-in each study period.
• Exclusion Criteria:
• • Females who are pregnant, lactating or likely to become pregnant during the study.
• • History of allergy or sensitivity to Furosemide, other thiazide, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
• • Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. Subjects with any history of hepatic disease or pancreatitis will be excluded.
• • Presence of gastrointestinal disease or history of malabsorption within the last year.
• • History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
• • Presence of a medical condition requiring regular treatment with prescription drugs.
• • Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
• • Receipt of any drug as part of a research study within 30 days prior to dosing.
• • Drug or alcohol addiction requiring treatment in the past 12 months.
• • Donation or significant loss of whole blood (480 ml or more) with/n 30 days or plasma within 14 days prior to dosing.
• • Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C ant/body.
• • Positive test results for drugs of abuse at screening.