HealthyPhase 1NCT01124162
Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions
A Phase 1 study testing Losartan and Cozaar® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial summary
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Losartan and Cozaar®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2003to Nov 2003
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Non-child-bearing potential female or male.
- Non-smoker.
- 18 years of age and older.
- Capable of consent.
- Non-child-bearing potential female subject:
- Post-menopausal state: absence of menses for 12 months prior to drug administration.
- Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
Who cannot join
- Clinically significant illness within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive urine drug screen at screening.
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- Positive testing for hepatitis B, hepatitis C, or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 100 bpm) at screening.
- Subjects with BMI > 30.0.
- History of significant alcohol abuse within 6 months prior to screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to the screening visit.
- History of allergic reactions to losartan or other related drugs.
- History of allergic reactions to heparin.
- Use of any drugs known to induce or inhibit drug metabolism within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowl diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the study drug.
- Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Positive alcohol breath test at screening.
- Subjects who have used tobacco in any form within 90 days preceding study drug administration.
- Any food allergy, intolerance, restriction, or special diet that could, in the opinion of the Medical Sub-Investigator, contraindicate the subjects participation in this study.
- A dept injection or an implant of any drug within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood prior to administration of the study medication as follows:
- Less than 300 mL of whole blood within 30 days
- 300 mL to 500 mL of whole blood within 45 days, or
- more than 500 mL of whole blood within 56 days prior to drug administration.
- Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
- Clinically significant history of known active hypotension or volume depletion.
- Intolerance to venipuncture.
- Clinically significant history of renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
- Subjects unable to understand or unwilling to sign the Informed Consent Form.
- Additional exclusion criteria for females only;
- Breast-feeding subjects.
- Positive urine pregnancy test at screening (performed for all females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-way Crossover, Bioequivalence Study of Losartan 100 mg Tablets and Cozaar® Administered as 1 * 100 mg Tablet in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
100 mg Tablet
Cozaar®Drug
Also called Losartan (generic name)
100 mg Tablet
| Study group | Role | What they receive |
|---|---|---|
| Generic Test Product | Experimental | Losartan 100mg Tablets Receives: Drug: Losartan |
| Reference Listed Drug | Active comparator | Cozaar® 100 mg Tablets Receives: Drug: Cozaar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Losartan Cmax.
Measured: Blood samples collected over a 24 hour period.
AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Losartan AUC0-t.
Measured: Blood samples collected over a 24 hour period.
AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Losartan AUC0-inf.
Measured: Blood samples collected over a 24 hour period.
Secondary outcomes (3)
Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)
Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.
Measured: Blood samples collected over a 24 hour period.
AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.
Measured: Blood samples collected over a 24 hour period.
AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for the metabolite Losaran Carboxy Acid.
Measured: Blood samples collected over a 24 hour period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startOct 2003
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Larouche, MD, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124162
- Sponsor's protocol ID
- 30272
- Status last verified
- Nov 2010
- First submitted
- 13 May 2010
- Last updated
- 8 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-way Crossover, Bioequivalence Study of Losartan 100 mg Tablets and Cozaar® Administered as 1 * 100 mg Tablet in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01124162
- Acronym / sponsor ID
- 30272
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 19 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic Test Product | Experimental | Drug: LosartanLosartan 100mg Tablets |
| Reference Listed Drug | Active comparator | Drug: Cozaar®Cozaar® 100 mg Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-child-bearing potential female or male.
- Non-smoker.
- 18 years of age and older.
- Capable of consent.
- Non-child-bearing potential female subject:
Key exclusion criteria (34 listed)
- Clinically significant illness within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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 |
|---|---|---|
| Losartan100 mg Tablet | Drug | Generic Test Product |
| Cozaar®Also: Losartan (generic name)100 mg Tablet | Drug | Reference Listed Drug |
Primary outcome
Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 24 hour period.
Bioequivalence based on Losartan Cmax.
AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 24 hour period.
Bioequivalence based on Losartan AUC0-t.
AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 24 hour period.
Bioequivalence based on Losartan AUC0-inf.
3 secondary outcomes
Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 24 hour period.
AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 24 hour period.
AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 24 hour period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Larouche, MD principal investigator
Anapharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Losartan and Cozaar® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
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 34 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 8 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 19 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 24 hour period.). The study lists 3 primary outcomes in all. 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 8 Dec 2010.