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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Candesartan Cilexetil; Drug: Candesartan (test); Drug: Felodipine; Drug: Felodipine (test)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00905333

D2452L00021

IMPACT 15381

Details and patient eligibility

About

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®

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not healthy
• Chronic drug intake

Trial design

36 participants in 1 patient group

Single-arm

Other group

Description:

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

Treatment:

Drug: Felodipine

Drug: Felodipine (test)

Drug: Candesartan Cilexetil

Drug: Candesartan (test)