Bioequivalence Study of Furosemide 80mg Tablets Under Fasting Conditions
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Purpose
The purpose of this study was to evaluate the relative bioavailability of the test formulation of furosemide 80 mg tablets (Ohm Laboratories, Inc.) with an already marketed reference formulation Lasix® (furosemide) 80 mg tablets (Aventis Pharmaceuticals NJ) under fasted conditions in healthy adult human subjects
| Condition | Intervention |
|---|---|
|
Healthy |
Drug: furosemide 80 mg tablets |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Study to Compare the Relative Bioavailability of Ranbaxy and Aventis Formulations of Furosemide 80 mg Tablets in Healthy Adult Volunteers Under Fasted Condition. |
- Bioequivalence [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | October 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
furosemide 80 mg tablets of Ranbaxy
|
Drug: furosemide 80 mg tablets |
|
Active Comparator: 2
Lasix® (furosemide) 80 mg tablets
|
Drug: furosemide 80 mg tablets |
Detailed Description:
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 study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
Blood samples were collected pre-dose and at intervals over 12 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to BA Research, 10550 Rockley Road, Suite 150, Houston, Texas 77099, Telephone: 281-495-6996, Fax 281-575-6996 for determination of furosemide plasma concentration.
Statistical analysis was performed at Ba Research, 2591 Sam Bass Road, Round Rock, TX 78681, Telephone 512-388-4554, Fax 512-388-4550.
A total of 44 subjects were randomized to receive single oral dose of 80 mg furosemide tablets and 39 subjects completed both the periods of the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Tausif Monif, Ranbaxy Research Labs |
| ClinicalTrials.gov Identifier: | NCT00778180 History of Changes |
| Other Study ID Numbers: | 10540344 |
| Study First Received: | October 22, 2008 |
| Last Updated: | October 22, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ranbaxy Inc.:
|
Bioequivalence furosemide 80 mg tablets |
Additional relevant MeSH terms:
|
Furosemide Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013