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Felodipine

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 7, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00905333Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific MealPHASE1 COMPLETED 36 — — Oct 1, 2008Nov 1, 2008Dec 7, 20102 Brazil
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Study Endpoints
Primary Endpoints
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
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Study Design & Arms
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Single-armOTHER3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
Interventions
NameTypeDescription
Candesartan (test)DRUG16 mg oral tablet, single dose
Felodipine (test)DRUG5 mg oral extended release tablet, single dose
Candesartan CilexetilDRUG16 mg oral tablet, single dose
FelodipineDRUG5 mg oral extended release tablet, single dose
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy volunteers * BMI \> or = 19 and \< or = 28 (Dietary Guidelines Advisory Committee, 2005) Exclusion Criteria: * Not healthy * Chronic drug intake

Countries:Brazil
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