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

NCT01149486 | Completed Phase 1 Results

• 1 other identifier: R04-080
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (6)

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

  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)

  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)

  Bioequivalence based on Losartan AUC0-inf.

  Blood samples collected over a 48 hour period.

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

  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)

  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)

  Bioequivalence based on Hydrochlorothiazide AUC0-inf.

  Blood samples collected over a 48 hour period.

Secondary Outcomes (3)

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

  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)

  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)

  Blood samples collected over a 48 hour period.

Study Arms (2)

Generic Test Product

EXPERIMENTAL

Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets

Drug: Losartan potassium/Hydrochlorothiazide

Reference Listed Drug

ACTIVE COMPARATOR

Hyzaar® 100/25 mg Tablets

Drug: Hyzaar®

Interventions

Losartan potassium/Hydrochlorothiazide DRUG

100/25 mg Tablets

Generic Test Product

Hyzaar® DRUG

100/25 mg Tablets

Also known as: Losartan potassium/Hydrochlorothiazide (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

hydrochlorothiazide, losartan drug combination; Losartan; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: TEVA Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James D Carlson, Pharm. D.

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: January 1, 2004
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: December 8, 2010
• Results First Posted: September 14, 2010

Record last verified: 2010-11

Locations

US (1)