HealthyPhase 1NCT01124175

Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions

A Phase 1 study testing Losartan and Cozaar® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 fed 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 or 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.

Show all 33Show fewer

ECG abnormalities (clinically significant) or vital sign abnormalities at screening.
Subjects with BMI greater than or equal to 30.0.
History of significant alcohol abuse within 6 months prior to the screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit equals 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
History of drug abuse of use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], or 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 of 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, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
Any clinically significant history or presence of 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 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 the 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 subject's participation in this study.
A depot 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 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 within 7 days prior to administration of the study medication.
Clinically significant history or known hypotension or volume depletion.
Intolerance to venipuncture.
Clinically significant history or renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
Subjects who are 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.

Canada1 site

Anapharm Inc.
Sainte-Foy, Quebec, G1V 2K8

Other trials in Canada

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 Fed 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 fed conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions: Healthy
Being tested: Losartan, Cozaar®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LosartanDrug
100 mg Tablets
Cozaar®Drug
Also called Losartan (generic name)
100 mg Tablets

Study groups in NCT01124175
Study group	Role	What they receive
Generic Test Product	Experimental	Losartan 100 mg 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 or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for the metabolite Losartan 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.

Oct 2003Nov 2003

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
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01124175
Sponsor's protocol ID: 30273
Status last verified: Aug 2024
First submitted: 13 May 2010
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. 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 Fed Conditions
ClinicalTrials.gov ID: NCT01124175
Acronym / sponsor ID: 30273
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 fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Generic Test Product	Experimental	Drug: LosartanLosartan 100 mg 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 or age and older.
Capable of consent.
Non-child-bearing potential female subject:

Key exclusion criteria (33 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 Tablets	Drug	Generic Test Product
Cozaar®Also: Losartan (generic name)100 mg Tablets	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 or 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

Results posted to the registry on 19 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan (Test) First	40	40
Cozaar® (Reference) First	40	40

Primary outcome: Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 24 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Losartan (Test) n = 77	Cozaar® (Reference) n = 77
Value	407.66 (209.45)	360.82 (183.42)

Losartan (Test) vs Cozaar® (Reference): Ratio of the T/R geometric mean x 100: 111.95 (90% CI 101.84 to 123.06)

Population analysed: All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Losartan (Test) n = 77	Cozaar® (Reference) n = 77
Value	915.12 (271.70)	864.29 (260.73)

Losartan (Test) vs Cozaar® (Reference): Ratio of the T/R geometric mean x 100: 105.97 (90% CI 103.61 to 108.39)

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Losartan (Test) n = 77	Cozaar® (Reference) n = 77
Value	926.82 (274.16)	877.73 (264.17)

Losartan (Test) vs Cozaar® (Reference): Ratio of the T/R geometric mean x 100: 105.67 (90% CI 103.32 to 108.07)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan (Test)	0 of 80 (0%)	5 of 80 (6.3%)	Not reported
Cozaar® (Reference)	0 of 80 (0%)	3 of 80 (3.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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 33 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 19 Aug 2024. 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?

On the ClinicalTrials.gov record for NCT01124175.

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 19 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.