HealthyPhase 1NCT01149486

Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions

A Phase 1 study testing Losartan potassium/Hydrochlorothiazide and Hyzaar® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Losartan potassium/Hydrochlorothiazide and Hyzaar®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jan 2004to Feb 2004
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 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men and women, 18-45 years of age (inclusive).
Body mass index should be less than or equal to 30
Screening procedures completed within 28 days prior to dosing.
If female and:
of child bearing potential, is practicing an acceptable barrier method of birth control for the duration of the study
is postmenopausal for at least 1 year
is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Who cannot join

Subjects with a recent history of drug or alcohol abuse or addiction.
Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
Subjects whose clinical laboratory test values the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
Subjects demonstrating a positive drug abuse screen when screened for the study.
Female subjects demonstrating a positive pregnancy screen.

Show all 18Show fewer

Female subjects who are currently breastfeeding.
Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or hormonal contraceptives within 14 days of dosing will not be allowed to participate.
Subjects with a history of allergic response(s) to losartan, hydrochlorothiazide or related drugs.
Subjects with a history of clinically significant allergies including drug allergies.
Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).
Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to dosing.
Subjects who have used tobacco products within 90 days of Period 1 dose administration.
Subjects who report donating greater than 150 mL of blood within 14 days prior to dosing.
Subjects who report receiving any investigational drug within 28 days prior to dosing.
Subjects who report taking any systemic prescription medication in the 14 days prior to dosing.
Subjects who report an intolerance of direct venipuncture.
Subjects who report consuming an abnormal diet within the 28 days prior to dosing.

Trial locations and contacts

1 site in 1 country.

United States1 site

PRACS Institute, Ltd.
Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Relative Bioavailability Study of 100/25 mg Losartan Potassium/Hydrochlorothiazide Tablets Under Fasting Conditions

The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions: Healthy
Being tested: Losartan potassium/Hydrochlorothiazide, Hyzaar®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

Losartan potassium/HydrochlorothiazideDrug
100/25 mg Tablets
Hyzaar®Drug
Also called Losartan potassium/Hydrochlorothiazide (generic name)
100/25 mg Tablets

Study groups in NCT01149486
Study group	Role	What they receive
Generic Test Product	Experimental	Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets Receives: Drug: Losartan potassium/Hydrochlorothiazide
Reference Listed Drug	Active comparator	Hyzaar® 100/25 mg Tablets Receives: Drug: Hyzaar®

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 48 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 48 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 48 hour period.
Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Hydrochlorothiazide Cmax.
Measured: Blood samples collected over a 48 hour period.
AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Hydrochlorothiazide AUC0-t.
Measured: Blood samples collected over a 48 hour period.
AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Hydrochlorothiazide AUC0-inf.
Measured: Blood samples collected over a 48 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 48 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 48 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 Losartan Carboxy Acid.
Measured: Blood samples collected over a 48 hour period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Feb 2004

First posted23 Jun 2010 (estimated)
Study startJan 2004
Primary completionFeb 2004
Study completionFeb 2004

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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01149486
Sponsor's protocol ID: R04-080
Status last verified: Nov 2010
First submitted: 21 Jun 2010
Last updated: 8 Dec 2010
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?

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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: A Relative Bioavailability Study of 100/25 mg Losartan Potassium/Hydrochlorothiazide Tablets Under Fasting Conditions
ClinicalTrials.gov ID: NCT01149486
Acronym / sponsor ID: R04-080
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Feb 2004 (actual)
Study completion: Feb 2004 (actual)
First posted: 23 Jun 2010 (estimated)
Results: Posted 14 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: Losartan potassium/HydrochlorothiazideLosartan potassium/Hydrochlorothiazide 100/25 mg Tablets
Reference Listed Drug	Active comparator	Drug: Hyzaar®Hyzaar® 100/25 mg Tablets

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy men and women, 18-45 years of age (inclusive).
Body mass index should be less than or equal to 30
Screening procedures completed within 28 days prior to dosing.
If female and:

Key exclusion criteria (18 listed)

Subjects with a recent history of drug or alcohol abuse or addiction.
Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
Subjects whose clinical laboratory test values the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
Subjects demonstrating a positive drug abuse screen when screened for the study.

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
Losartan potassium/Hydrochlorothiazide100/25 mg Tablets	Drug	Generic Test Product
Hyzaar®Also: Losartan potassium/Hydrochlorothiazide (generic name)100/25 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 48 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 48 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 48 hour period.
Bioequivalence based on Losartan AUC0-inf.
Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 48 hour period.
Bioequivalence based on Hydrochlorothiazide Cmax.
AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 48 hour period.
Bioequivalence based on Hydrochlorothiazide AUC0-t.
AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 48 hour period.
Bioequivalence based on Hydrochlorothiazide 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 48 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 48 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 48 hour period.

Results and safety

Results posted to the registry on 14 Sep 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/HCTZ (Test) First	10	10
Hyzaar® (Reference) First	10	9

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

Time frame: Blood samples collected over a 48 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Losartan/HCTZ (Test) n = 19	Hyzaar® (Reference) n = 19
Value	509.63 (314.75)	538.11 (298.89)

Losartan/HCTZ (Test) vs Hyzaar® (Reference): Ratio of the T/R geometric mean x 100: 93.45 (90% CI 80.20 to 108.88)

Population analysed: All participants that completed the study had their samples analyzed.

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 48 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Losartan/HCTZ (Test) n = 19	Hyzaar® (Reference) n = 19
Value	866.88 (366.15)	865.00 (362.86)

Losartan/HCTZ (Test) vs Hyzaar® (Reference): Ratio of the T/R geometric mean x 100: 99.45 (90% CI 93.15 to 106.18)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)

Time frame: Blood samples collected over a 48 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Losartan/HCTZ (Test) n = 19	Hyzaar® (Reference) n = 19
Value	880.15 (368.58)	877.99 (362.75)

Losartan/HCTZ (Test) vs Hyzaar® (Reference): Ratio of the T/R geometric mean x 100: 99.4 (90% CI 93.10 to 106.12)

Population analysed: All participants that completed the study had their samples analyzed.

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

Time frame: Blood samples collected over a 48 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Losartan/HCTZ (Test) n = 19	Hyzaar® (Reference) n = 19
Value	177.63 (48.09)	161.56 (53.75)

Losartan/HCTZ (Test) vs Hyzaar® (Reference): Ratio of the T/R geometric mean x 100: 111.62 (90% CI 101.47 to 122.79)

Population analysed: All participants that completed the study had their samples analyzed.

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/HCTZ (Test)	0 of 20 (0%)	3 of 20 (15%)	Not reported
Hyzaar® (Reference)	0 of 20 (0%)	6 of 20 (30%)	Not reported

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.

James D Carlson, Pharm. D. principal investigator

PRACS Institute, Ltd.

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 potassium/Hydrochlorothiazide and Hyzaar® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

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 18 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 United States. 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 14 Sep 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 48 hour period.). The study lists 6 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 NCT01149486.

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; AzTrials last refreshed its copy on 7 Nov 2026.