Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fed Conditions

This study has been completed.

Sponsor:

Information provided by:

Roxane Laboratories

ClinicalTrials.gov Identifier:

NCT01216878

First received: October 6, 2010

Last updated: NA

Last verified: October 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 6, 2010

Last Updated Date

October 6, 2010

Start Date ^ICMJE

September 2004

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

bioequivalence determined by statistical comparison Cmax [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fed Conditions

Official Title ^ICMJE

A Single Dose, 2-Period, 2-Treatment Bioequivalency Study of Losartan Potassium Tablets 100 mg Under Fed Conditions

Brief Summary

The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet under fasted conditions.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: losartan potassium

100 mg tablet

Other Name: COZAAR

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2004

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to losartan potassium or any comparable or similar product.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01216878

Other Study ID Numbers ^ICMJE

LOSA-02

Has Data Monitoring Committee

Responsible Party

Elizabeth Ernst, Director - Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.

Study Sponsor ^ICMJE

Roxane Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dennis N. Morrison, D.O.

Bio-Kinetic Clinical Applications, Inc.

Information Provided By

Roxane Laboratories

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top