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CompletedNCT00905333Updated Dec 7, 2010

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

A Phase 1 interventional study of Candesartan (test) and Felodipine (test) in Healthy, sponsored by AstraZeneca. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-07.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
36
Ages
18 Years to 50 Years
Sex
All
01

Study 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®

02

Conditions studied

  • Healthy

Keywords

  • 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.
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not healthy
  • Chronic drug intake
05

Study design

Phase
Phase 1
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Other
    Single-arm

    3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)

    Drug: Candesartan (test) · Drug: Felodipine (test) · Drug: Candesartan Cilexetil · Drug: Felodipine

Interventions

  • DrugCandesartan (test)

    16 mg oral tablet, single dose

  • DrugFelodipine (test)

    5 mg oral extended release tablet, single dose

  • DrugCandesartan Cilexetil

    16 mg oral tablet, single dose

    Also known as: Atacand®

  • DrugFelodipine

    5 mg oral extended release tablet, single dose

    Also known as: Splendil®

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

2 sites
  • Research Site
    Itatiba, SP, Brazil
  • Research Site
    Americana, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00905333
Lead sponsor
AstraZeneca
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., Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
First posted
May 20, 2009
Start date
Oct 2008
Primary completion
Nov 2008
Completion
Nov 2008
Last update
Dec 7, 2010

Study contacts

Eduardo Abib Junior, MD
principal investigator · Scentryphar Clinical Research
Moises L. P Vanuncci, MD
study chair · Scentryphar Clinical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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