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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905333
• Other study ID #: D2452L00021
• Secondary ID: IMPACT 15381
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2009
• Last updated: December 6, 2010
• Start date: October 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

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

Exclusion Criteria:

• Not healthy

• Chronic drug intake

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Candesartan (test)
16 mg oral tablet, single dose
• Felodipine (test)
5 mg oral extended release tablet, single dose
• Candesartan Cilexetil
16 mg oral tablet, single dose
• Felodipine
5 mg oral extended release tablet, single dose

Locations

Country	Name	City	State
Brazil	Research Site	Americana
Brazil	Research Site	Itatiba	SP

Sponsors (7)

Lead Sponsor	Collaborator
AstraZeneca	Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C, Cori Analyticals, Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência, LabClin Laboratório Clínico, Laboratório de Patologia Clínica Dr. Franceschi Ltda., Scentryphar Clinical Research

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®.		76 blood samples per subject	Yes