Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone

Exclusion Criteria

• •Any of the following conditions are cause for exclusion from the study:
• •1. History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal, psychiatric disease/disorder.
• •2. History or presence of significance:
• •Asthma, urticaria, or other allergic-type reactions after taking Torsemide, Spironolactone or any other drug.
• •Ulceration or history of gastric and/or duodenal ulcer. Stomach or intestinal bleeding. Jaundice in the past 6 months. Internal bleeding.
• •3. Hypersensitivity or allergy to Torsemide, Spironolactone or any of the excipients.
• •4. History of alcohol or drug abuse in the past one year.
• •5. Family history of bleeding disorders.
• •6. History of difficulty in passing urine or emptying the bladder or of incontinence.
• •7. Have donated 500 mL or more blood within 90 days before receiving the first dose of the study drug.
• •8. Subjects who have participated in another clinical study in the past 3 months prior to commencement of this study.
• •9. Any difficulty in the accessibility of forearm veins for cannulation or blood sampling and or difficulty with donating blood.
• •10. Refuse to abstain from food for at least 10 h prior to dosing and for at least 4 h after dosing in each period.
• •11. Refuse to abstain from fluid for at least 1 h before and 1 h after dosing in each period (except 240 ± 2 mL water given for dosing).
• •12. Found positive during breath alcohol test done during period one check-in and inability to abstain from alcohol till the end of the study.
• •13. Found positive during urine drug screening done prior to period one check-in.
• •14. Found positive screening results for Hepatitis B, Hepatitis C, HIV, or Syphilis.
• •15. History of difficulty in swallowing tablets.
• •16. Received any medication \[including over-the-counter products\], herbal products for 14 days preceding the study.
• •17. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
• •18. History of dehydration from diarrhea, vomiting, or any other reason within 24 hours prior to check-in of period one.
• •19. Consumption of xanthine-containing food and beverages (chocolates, tea, coffee, or cola drinks) for at least 48 hours prior to check-in of period one.
• •20. Consumption of grapefruit or its products within the 48 hours prior to check-in of period one.
• •21. Female subjects are found to be positive during pregnancy tests done prior to period one check-in.
• •22. Lactating females.
• •23. Investigator/Physician feels that it is not in the subject's and/or study's best interest to enroll the subject.