Clinical trial NCT01149486: Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
Official title: A Relative Bioavailability Study of 100/25 mg Losartan Potassium/Hydrochlorothiazide Tablets Under 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: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
* 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.

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 Hydroclorothiazide(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:
measure: Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)
timeFrame: Blood samples collected over a 48 hour period.
measure: AUC0-t of Losartan Carboxy Acid(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 Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
timeFrame: Blood samples collected over a 48 hour period.
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: