Evaluation of the Pharmacokinetic Interaction between Candesartan and Felodipine after ingestion of a specific meal
Study identifier:D2452L00021
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Candesartan (test), Felodipine (test), Candesartan Cilexetil, Felodipine
Sex
All
Actual Enrollment
36
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Oct 2008
Primary Completion Date: 01 Nov 2008
Study Completion Date: 01 Nov 2008
Study design
Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
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
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Other: 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® |
Contacts
Investigators
Principal Investigator
Eduardo Abib Junior
Scentryphar Clinical Research
