Bioavailability Study of Torsemide Tablets Under Fasting Conditions

To Determine Bioequivalence Under Fasting Conditions Clinical Trial

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 Fasting Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653549
• Other study ID #: 01169
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2008
• Last updated: June 16, 2011
• Start date: April 2001
• Est. completion date: May 2001

Study information

• Verified date: June 2011
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2001
• Est. primary completion date: May 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 the 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.

• 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%)

• 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 has 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• To Determine Bioequivalence Under Fasting Conditions

Intervention

Drug:
• Torsemide
Tablets, 20 mg, single-dose
• Demadex
tablets, 20 mg, single-dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	Anapharm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and Extend of Absorption		24 hours	No