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Completed

NCT Number: NCT00905333

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

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®

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Itatiba, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not healthy
  • Chronic drug intake

Treatment and study plan

Candesartan (test)

Drug

16 mg oral tablet, single dose

Felodipine (test)

Drug

5 mg oral extended release tablet, single dose

Candesartan cilexetil

Drug

16 mg oral tablet, single dose

Other names: Atacand®

Felodipine

Drug

5 mg oral extended release tablet, single dose

Other names: Splendil®

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Cori Analyticals
  • Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
  • Hospital Sirio-Libanes
  • LabClin Laboratório Clínico
  • Laboratório de Patologia Clínica Dr. Franceschi Ltda.
  • Scentryphar Clinical Research

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 20, 2009
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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