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Bioequivalence Study in Healthy Subjects

NCT ID: NCT00844324

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

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.

Detailed Description

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Conditions

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Hypertension

Keywords

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Candesartan Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Candesartan cilexetil 1mg/mL

Group Type EXPERIMENTAL

Candesartan cilexetil

Intervention Type DRUG

Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose

B

Candesartan cilexetil 1.6mg/mL

Group Type EXPERIMENTAL

Candesartan cilexetil

Intervention Type DRUG

Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose

Interventions

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Candesartan cilexetil

Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose

Intervention Type DRUG

Candesartan cilexetil

Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Body mass index (BMI) 19-27 kg/m2 calculated from height and weight at the Screening visit
* Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs-of-abuse, alcohol, Hepatitis B, Hepatitis C and HIV.

Exclusion Criteria

* History of significant mental, cardiac, renal, hepatic or significant gastrointestinal disease (that may affect the rate and extent of absorption of the IP), as judged by the Investigator
* Any condition which could modify the absorption of the IPs
* Previous randomisation of treatment in the present study
* History or symptoms and signs of ongoing severe allergic disease/hypersensitivity
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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James Hainer, MD

Role: STUDY_DIRECTOR

AstraZeneca

Klaus Francke, Dr

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Research Site

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D2451C00007

Identifier Type: -

Identifier Source: org_study_id