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

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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00905333
Enrollment
36
Registered
2009-05-20
Start date
2008-10-31
Completion date
2008-11-30
Last updated
2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Brief 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®

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

DRUGFelodipine

5 mg oral extended release tablet, single dose

Sponsors

Scentryphar Clinical Research
CollaboratorOTHER
Cori Analyticals
CollaboratorUNKNOWN
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
CollaboratorUNKNOWN
LabClin Laboratório Clínico
CollaboratorUNKNOWN
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
CollaboratorUNKNOWN
Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
CollaboratorOTHER
AstraZeneca
Lead SponsorINDUSTRY

Study design

Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Not healthy * Chronic drug intake

Design outcomes

Primary

MeasureTime frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026