Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone

Inclusion criteria

• . Healthy human adult subjects within the age range of 18 to 45 years \[both inclusive\].
• . Weight not less than 50 kg for male and 45 kg for female and BMI 18.50 to 29.99 kg/m2 \[both inclusive\].
• . Willingness to provide written informed consent to participate in the study.
• . Subjects should be non-smoker \[defined as someone who has stopped smoking for a year before the date of screening\] and should not be consuming tobacco containing products.
• . Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray \[PA view\].
• . Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
• . Subject should be literate.
• . Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and upto the study completion visit. Subjects must refrain from fathering a child in the next two weeks following the last study drug administration or have undergone vasectomy (vasectomy must have been done more than 6 months prior to first dosing). Contraceptive usage requirement will be conveyed during the inform consent process. Subjects will be advised to follow effective method of contraception until 2 weeks after the last dose is given.

Exclusion criteria