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Bioavailability Study of Torsemide Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Collaborator:
Anapharm
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00654043
First received: April 1, 2008
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Torsemide
Drug: Demadex
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Single-Dose, 2 Way Cross Over Bioavailability Study of Par Torsemide Tablets 20mg With That of Roche Demadex 1*20 mg in Healthy Subjects Under Fed Conditions.

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2001
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects received Par formulated products under fed conditions
Drug: Torsemide
tablets, 20 Mg, single-dose
Other Name: Demadex
Active Comparator: B
Subjects received Roche formulated products
Drug: Demadex
Tablets, 20 mg, single-dose
Other Name: Torsemide

Detailed Description:

To compare the single -dose bioavailability of Par Torsemide tablets 20mg with that Roche Demadex 1*20mg tablets under fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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, 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 sis 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%)
  • History of drug abuse or use of illegal drugs: Use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year of the screening visit.
  • Subjects who have taken prescription medication within 14 days prior to administration of study medication or over the counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Female subjects of childbearing potential having unprotected sexual intercourse with any non- sterile male partner (i.e. male who ahs not been sterilized by vasectomy for al least 6 months) within 14 days prior to study drug administration. The Acceptable methods of contraception are :
  • Condom+ spermicide (within 14 days prior to study drug administration)
  • Diaphragm + spermicide (within 14 days prior to study drug administration.
  • Intrauterine contraceptive device (place al least 4 weeks prior to study drug administration)
  • Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication.
  • examples of inducers: barbiturates, carbamazepine, phenytoin,glucocorticoids, rifampin/rifabutin;; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine)
  • Subjects who have undergone clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654043

Sponsors and Collaborators
Par Pharmaceutical, Inc.
Anapharm
Investigators
Principal Investigator: Eric Masson Anapharm
  More Information

No publications provided

Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00654043     History of Changes
Other Study ID Numbers: 01170
Study First Received: April 1, 2008
Last Updated: April 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence
Torsemide Tablets
fed
To determine bioequivalence under fed conditions.

Additional relevant MeSH terms:
Torsemide
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014