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Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305

NCT ID: NCT00689403

Last Updated: 2010-12-03

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

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To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.

Detailed Description

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Conditions

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Healthy

Keywords

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AZD1305 pharmacokinetics Properties of different ER formulations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: 2x2 crossover

4 different AZD1305 ER formulations

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Extended release capsules, oral single doses

Part B: 3x3 crossover

2 different AZD1305 ER formulations and a reference formulation

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Extended release capsules, oral single doses

Interventions

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AZD1305

Extended release capsules, oral single doses

Intervention Type DRUG

AZD1305

Extended release capsules, oral single doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male between the age of 20 - 45
* Non-smoking

Exclusion Criteria

* Potassium outside normal reference values
* ECG findings outside normal range
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

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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Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Daniel Bradford, MD, MA, MBBS, DCPSA

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom

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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D3190C00014

Identifier Type: -

Identifier Source: org_study_id