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

AstraZeneca36 enrolled

Overview

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 Type

INTERVENTIONAL

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Candesartan (test)DRUG

16 mg oral tablet, single dose

Felodipine (test)DRUG

5 mg oral extended release tablet, single dose

Candesartan CilexetilDRUG

16 mg oral tablet, single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers * BMI \> or = 19 and \< or = 28 (Dietary Guidelines Advisory Committee, 2005) Exclusion Criteria: * Not healthy * Chronic drug intake

Locations (2)

Research Site

Itatiba, São Paulo, Brazil

Research Site

Americana, Brazil

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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