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

NCT ID: NCT00905333

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Healthy

Keywords

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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.

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Single-arm

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

Group Type OTHER

Candesartan (test)

Intervention Type DRUG

16 mg oral tablet, single dose

Felodipine (test)

Intervention Type DRUG

5 mg oral extended release tablet, single dose

Candesartan Cilexetil

Intervention Type DRUG

16 mg oral tablet, single dose

Felodipine

Intervention Type DRUG

5 mg oral extended release tablet, single dose

Interventions

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Candesartan (test)

16 mg oral tablet, single dose

Intervention Type DRUG

Felodipine (test)

5 mg oral extended release tablet, single dose

Intervention Type DRUG

Candesartan Cilexetil

16 mg oral tablet, single dose

Intervention Type DRUG

Felodipine

5 mg oral extended release tablet, single dose

Intervention Type DRUG

Other Intervention Names

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Atacand® Splendil®

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not healthy
* Chronic drug intake
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scentryphar Clinical Research

OTHER

Sponsor Role collaborator

Cori Analyticals

UNKNOWN

Sponsor Role collaborator

Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C

UNKNOWN

Sponsor Role collaborator

LabClin Laboratório Clínico

UNKNOWN

Sponsor Role collaborator

Laboratório de Patologia Clínica Dr. Franceschi Ltda.

UNKNOWN

Sponsor Role collaborator

Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Eduardo Abib Junior, MD

Role: PRINCIPAL_INVESTIGATOR

Scentryphar Clinical Research

Moises L. P Vanuncci, MD

Role: STUDY_CHAIR

Scentryphar Clinical Research

Locations

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Research Site

Itatiba, São Paulo, Brazil

Site Status

Research Site

Americana, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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IMPACT 15381

Identifier Type: -

Identifier Source: secondary_id

D2452L00021

Identifier Type: -

Identifier Source: org_study_id