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
Summary
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®.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
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