Bioavailability Study of Torsemide Tablets Under Fed Conditions (NCT00654043) | Clinical Trial Compass
CompletedPhase 1
Bioavailability Study of Torsemide Tablets Under Fed Conditions
24 participantsStarted 2001-04
Plain-language summary
To compare the single-dose bioavailability of Torsemide tablets with Demadex
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects enrolled in the study will be members of the community at large.
* The Recruitment will be done by radio, newspapers and Anapharm Inc.
* Anapharm Website advertisements. Subjects must meet all the following criteria in order to be included in the study.
* Subjects will be male and / or female, smokers and non-smokers, 18 years of age and older.
* Subjects should read, sign, and date an Informed Consent form prior to ant study procedures.
* Subjects must complete all screening procedures within 28 days prior to the administration of the study medication.
Exclusion Criteria:
* Breast feeding female subjects.
* Any clinically significant abnormality found during medical screening and subjects with BMI ≥30
* Any Clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases) or unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), susceptible of interfering with the absorption of drugs.
* Clinically significant illness within 4 weeks prior to the administration of the study medication.Abnormal laboratory tests judged clinically significant
* ECG abnormalities (clinically significant) (PR interval greater than 225ms);or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 60 or over 95 mmHg, or heart rate less than 60 bpm) at screening.
* History of allergic reactions to torsemide or sulfonylureas (e.g. tolbutamide, chlorpropamide, gly…