Bioavailability Study of Torsemide Tablets Under Fasting Conditions

NCT00653549 | Completed Phase 1

• 1 other identifier: 01169
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the single-dose bioavailability of Torsemide tablets with Demadex

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

Bioequivalence; Torsemide Tablets; fasting

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  24 hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received Par formulated product under fasting conditions

Drug: Torsemide

B

ACTIVE COMPARATOR

Subjects received Roche formulated product under fasting conditions

Drug: Demadex

Interventions

Torsemide DRUG

Tablets, 20 mg, single-dose

Also known as: Demadex

A

Demadex DRUG

tablets, 20 mg, single-dose

Also known as: Torsemide

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the study procedures.
• Subjects must complete all screening procedures within 28 days prior to the administration of the study medication.

You may not qualify if:

• Breast- feeding female subjects.
• Any clinically significant abnormality found during medical screening.
• 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, glyburide and gliclazide) or other related drugs ( e.g. furosemide, bumetanide, sulfabenzamide, sulfacetamide, sulfathiazole, sulfadiazine, sulfamethoxazole, sulfasalazine, sulfisoxazole and dapsone).
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub- Investigator, could contraindicate the subject's participation in this study.
• Positive urine drug screen at screening.
• Positive testing for hepatitis B, hepatitis C, or HIV at screening.
• Positive urine pregnancy test at screening.(performed on all female subjects)
• Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
• Donation of plasma ( 500 mL) within 7 days or donation of significant loss of whole blood (450 mL) within 56 days prior to administration of the study medication.
• History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 ml of alcohol 40%)

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Anapharm: collaborator

MeSH Terms

Conditions

Fasting

Interventions

Torsemide

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eric Masson

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 7, 2008
• Study Start: April 1, 2001
• Primary Completion: May 1, 2001
• Study Completion: May 1, 2001
• Last Updated: June 17, 2011

Record last verified: 2011-06