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

This study has been completed.
Sponsor:
Collaborators:
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00905333
First received: May 19, 2009
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

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®


Condition Intervention Phase
Healthy
Drug: Candesartan (test)
Drug: Felodipine (test)
Drug: Candesartan Cilexetil
Drug: Felodipine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: October 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
Drug: Candesartan (test)
16 mg oral tablet, single dose
Drug: Felodipine (test)
5 mg oral extended release tablet, single dose
Drug: Candesartan Cilexetil
16 mg oral tablet, single dose
Other Name: Atacand®
Drug: Felodipine
5 mg oral extended release tablet, single dose
Other Name: Splendil®

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not healthy
  • Chronic drug intake
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905333

Locations
Brazil
Research Site
Itatiba, SP, Brazil
Research Site
Americana, Brazil
Sponsors and Collaborators
AstraZeneca
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência
Investigators
Principal Investigator: Eduardo Abib Junior, MD Scentryphar Clinical Research
Study Chair: Moises L. P Vanuncci, MD Scentryphar Clinical Research
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00905333     History of Changes
Other Study ID Numbers: D2452L00021, IMPACT 15381
Study First Received: May 19, 2009
Last Updated: December 6, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by AstraZeneca:
pharmacokinetics
candesartan
felodipine
test formulations
Atacand®
Splendil®
healthy volunteers
blood samples
after meal intake interaction
Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.

Additional relevant MeSH terms:
Felodipine
Candesartan cilexetil
Candesartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 19, 2014