To Determine Bioequivalence Under Fasting ConditionsPhase 1NCT00653549
Bioavailability Study of Torsemide Tablets Under Fasting Conditions
A Phase 1 study testing Torsemide and Demadex in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc..
Trial summary
To compare the single-dose bioavailability of Torsemide tablets with Demadex Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fasting Conditions
- What is being tested?
- Torsemide and Demadex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to May 2001
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
To compare the single-dose bioavailability of Torsemide tablets with Demadex
Read the detailed description
To compare the single -dose bioavailability of Par Torsemide tablets 20mg with that Roche Demadex 1*20mg tablets under fasting conditions.
- Being tested
- Torsemide, Demadex
- Keywords
- Bioequivalence, Torsemide Tablets, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TorsemideDrug
Also called Demadex
Tablets, 20 mg, single-dose
DemadexDrug
Also called Torsemide
tablets, 20 mg, single-dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received Par formulated product under fasting conditions Receives: Drug: Torsemide |
| B | Active comparator | Subjects received Roche formulated product under fasting conditions Receives: Drug: Demadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startApr 2001
- Primary completionMay 2001
- Study completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fasting ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Investigators
- Eric Masson, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653549
- Sponsor's protocol ID
- 01169
- Status last verified
- Jun 2011
- First submitted
- 1 Apr 2008
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00653549
- Acronym / sponsor ID
- 01169
- Keywords
- Bioequivalence, Torsemide Tablets, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Study start
- Apr 2001
- Primary completion
- May 2001 (actual)
- Study completion
- May 2001 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the single-dose bioavailability of Torsemide tablets with Demadex
Detailed description
To compare the single -dose bioavailability of Par Torsemide tablets 20mg with that Roche Demadex 1*20mg tablets under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: TorsemideSubjects received Par formulated product under fasting conditions |
| B | Active comparator | Drug: DemadexSubjects received Roche formulated product under fasting conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TorsemideAlso: DemadexTablets, 20 mg, single-dose | Drug | A |
| DemadexAlso: Torsemidetablets, 20 mg, single-dose | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Masson principal investigator
Anapharm
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Torsemide and Demadex in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Extend of Absorption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.