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

NCT01149473 | Completed Phase 1 Results

• 1 other identifier: B046515
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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 Hydrochlorothiazide(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.

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: Losartan potassium/Hydrochlorothiazide

Interventions

Losartan potassium/Hydrochlorothiazide DRUG

100/25 mg Tablets

Generic Test Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

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

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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: March 1, 2004
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: August 20, 2024
• Results First Posted: September 14, 2010

Record last verified: 2024-08

Locations

US (1)