A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

April 26, 2011 updated by: Hanmi Pharmaceutical Company Limited

A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects

Study Design :

  • A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Primary Objective:

  • To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Secondary Objective:

  • To evaluate the safety and tolerability of these formulations.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-55 years
  • Healthy Caucasian volunteers
  • Non smokers or mild smokers

Exclusion criteria:

  • Pregnancy and/or breast-feeding
  • Participation in another clinical trial within 60 days prior to Period 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlodipine plus Losartan
Drug: Amlodipine plus Losartan
Amlodipine/Losartan low dose
Active Comparator: Amlodipine, Losartan
Drug: Amlodipine, Losartan
Amlodipine, Losartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC, Cmax
Time Frame: 0-144hrs
0-144hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 27, 2011

Last Update Submitted That Met QC Criteria

April 26, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-ALOS-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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