Bioavailability Study of Torsemide Tablets Under Fed Conditions

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Torsemide; Drug: Demadex

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Subjects received Par formulated products under fed conditions	Drug: Torsemide; tablets, 20 Mg, single-dose; Other Names: Demadex
ACTIVE_COMPARATOR: B; Subjects received Roche formulated products	Drug: Demadex; Tablets, 20 mg, single-dose; Other Names: Torsemide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	24 Hours

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: Anapharm

Study record dates

Study Major Dates

• Study Start: April 1, 2001
• Primary Completion (ACTUAL): May 1, 2001
• Study Completion (ACTUAL): May 1, 2001

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (ESTIMATE): April 7, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 11, 2008
• Last Update Submitted That Met QC Criteria: April 10, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Bioequivalence; fed; Torsemide Tablets; To determine bioequivalence under fed conditions.
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Torsemide
• Other Study ID Numbers: 01170