Clinical trial NCT01149473: Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
Official title: A Relative Bioavailability Study of Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets Under Non-Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2010-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
timeFrame: Blood samples collected over a 48 hour period.
measure: AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
timeFrame: Blood samples collected over a 48 hour period.
measure: AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
timeFrame: Blood samples collected over a 48 hour period.
measure: Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
timeFrame: Blood samples collected over a 48 hour period.
measure: AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
timeFrame: Blood samples collected over a 48 hour period.
measure: AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
timeFrame: Blood samples collected over a 48 hour period.
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd.
name: James D Carlson, Pharm D
role: PRINCIPAL_INVESTIGATOR
References: