Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00905333
- Lead Sponsor
- AstraZeneca
- 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®
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Healthy volunteers
- BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)
Exclusion Criteria
- Not healthy
- Chronic drug intake
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Single-arm Candesartan (test) 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) Single-arm Felodipine (test) 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) Single-arm Felodipine 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) Single-arm Candesartan Cilexetil 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇧🇷Americana, Brazil