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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Candesartan (test) (Drug); Felodipine (test) (Drug); Candesartan Cilexetil (Drug); Felodipine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Eduardo Abib Junior, MD, Principal Investigator, Affiliation: Scentryphar Clinical Research
Moises L. P Vanuncci, MD, Study Chair, Affiliation: Scentryphar Clinical Research


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®

Clinical Details

Official 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.

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: 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®.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy volunteers

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

Exclusion Criteria:

- Not healthy

- Chronic drug intake

Locations and Contacts

Research Site, Americana, Brazil

Research Site, Itatiba, SP, Brazil

Additional Information

Starting date: October 2008
Last updated: December 6, 2010

Page last updated: August 23, 2015

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