Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

December 6, 2010 updated by: AstraZeneca

Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.

The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Brazil
      • Americana, Brazil
        • Research Site
    • SP
      • Itatiba, SP, Brazil
        • Research Site

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 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)

Exclusion Criteria:

  • Not healthy
  • Chronic drug intake

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
Drug: Candesartan (test)
16 mg oral tablet, single dose
Drug: Felodipine (test)
5 mg oral extended release tablet, single dose
Drug: Candesartan Cilexetil
16 mg oral tablet, single dose
Other Names:
  • Atacand®
Drug: Felodipine
5 mg oral extended release tablet, single dose
Other Names:
  • Splendil®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.
Time Frame: 76 blood samples per subject
76 blood samples per subject

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center

Investigators

  • Principal Investigator: Eduardo Abib Junior, MD, Scentryphar Clinical Research
  • Study Chair: Moises L. P Vanuncci, MD, Scentryphar Clinical Research

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

October 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

December 7, 2010

Last Update Submitted That Met QC Criteria

December 6, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2452L00021
  • IMPACT 15381

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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