Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects
brief summary
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone). The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone® (Spironolactone) alone, and 10 mg Torsemide and 25 mg Aldactone® (Spironolactone) taken together in healthy subjects.
detailed description
Screening and Study Assessments Demographic data, medical, surgical and medication histories, physical examination, height, weight and BMI as well as 12 lead ECG, chest X-ray \[PA view\], vital signs \[blood pressure, pulse rate, respiratory rate and oral temperature\], Oxygen Saturation (SpO2 %), hematology, biochemistry, HIV 1 \& 2, Hepatitis B and C, RPR test for Syphilis and urinalysis will be done at screening. Females will undergo a serum pregnancy test at the time of screening.
Urine drug screen and breath alcohol test will be done prior to each check-in. Urine pregnancy test will be performed for females prior to each check-in.
Study Duration The total expected study duration is at least 27 days from the day of check-in for Period 1 to the end of Period 4. In case of any post-study laboratory parameter abnormalities, the subject will be followed up at the investigator's discretion.
Washout Period A washout period of at least 07 days will be maintained in between the periods.
Housing Subjects will be housed in the facility from at least 36 hours prior to day of dosing until at least 72 hours post-dose in each period.
Treatments
Treatments Administered:
Treatment (A): 10 mg Torsemide tablet Dose: 1x 10 mg tablet Route of Administration: Oral
Treatment (B): 25 mg Aldactone® (Spironolactone) tablet Dose: 1x 25 mg tablet Route of Administration: Oral
Treatment (C): FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet. Dose: 1x (12 mg + 15 mg) FDC tablet Route of Administration: Oral
Treatment (D): 10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together Dose: 1x 10 mg Torsemide tablet + 1x 25 mg Spironolactone tablet Route of Administration: Oral
Blood and Urine Sampling
All subjects will be given a labeled container for urine collection in each period.
Blood samples will be collected in each period.
Adverse and serious adverse events will be monitored throughout the study.
official title
Bioavailability and Bioequivalence (BA/BE) Study of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Subjects