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

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Losartan potassium/Hydrochlorothiazide (Drug); Hyzaar® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
James D Carlson, Pharm. D., Principal Investigator, Affiliation: PRACS Institute, Ltd.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

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

AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

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

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

AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)

Secondary outcome:

Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)

AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

PRACS Institute, Ltd., Fargo, North Dakota 58104, United States
Additional Information

Starting date: January 2004
Last updated: November 22, 2010

Page last updated: August 23, 2015

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