- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01149473
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
August 16, 2010 updated by: Teva Pharmaceuticals USA
A Relative Bioavailability Study of Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- PRACS Institute, Ltd.
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, non-smoking, male and female subjects at least 18 years of age.
- BMI (body mass index) of 30 or less.
- Females in this study must be physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile).
- Successful completion of a physical examination within 28 days of initiation of the study.
- Negative serum pregnancy test (females).
Exclusion Criteria:
- Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis, or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are outside the reference range and are deemed clinically significant by the Principle Investigator.
- Subjects who have a history of allergic responses to the classes of drugs being tested will be excluded from the study.
- Subjects who use tobacco in any form will not be eligible to participate in the study. 3 months abstinence is required.
- Subjects found to have urine concentrations of any of the tested drugs of abuse will not be allowed to participate.
- Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.
- Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate.
- Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
- All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
- Subjects who do not tolerate venipuncture will not be allowed to participate.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Generic Test Product
Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets
|
100/25 mg Tablets
Other Names:
|
ACTIVE_COMPARATOR: Reference Listed Drug
Hyzaar® 100/25 mg Tablets
|
100/25 mg Tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
Time Frame: Blood samples collected over a 48 hour period.
|
Bioequivalence based on Losartan AUC0-t.
|
Blood samples collected over a 48 hour period.
|
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.
|
Blood samples collected over a 48 hour period.
|
Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Time Frame: Blood samples collected over a 48 hour period.
|
Bioequivalence based on Hydrochlorothiazide Cmax.
|
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)
Time Frame: Blood samples collected over a 48 hour period.
|
Bioequivalence based on Hydrochlorothiazide AUC0-t.
|
Blood samples collected over a 48 hour period.
|
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.
|
Blood samples collected over a 48 hour period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2004
Primary Completion (ACTUAL)
April 1, 2004
Study Completion (ACTUAL)
April 1, 2004
Study Registration Dates
First Submitted
June 21, 2010
First Submitted That Met QC Criteria
June 22, 2010
First Posted (ESTIMATE)
June 23, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 14, 2010
Last Update Submitted That Met QC Criteria
August 16, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Losartan
- Hydrochlorothiazide
Other Study ID Numbers
- B046515
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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