- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653549
Bioavailability Study of Torsemide Tablets Under Fasting Conditions
June 16, 2011 updated by: Par Pharmaceutical, Inc.
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.
To compare the single-dose bioavailability of Torsemide tablets with Demadex
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To compare the single -dose bioavailability of Par Torsemide tablets 20mg with that Roche Demadex 1*20mg tablets under fasting conditions.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Subjects received Par formulated product under fasting conditions
|
Tablets, 20 mg, single-dose
Other Names:
|
Active Comparator: B
Subjects received Roche formulated product under fasting conditions
|
tablets, 20 mg, single-dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate and Extend of Absorption
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
June 17, 2011
Last Update Submitted That Met QC Criteria
June 16, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01169
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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