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Study of an Extended Release (ER) Tablet, Single and Repeated Dosing

NCT ID: NCT00689039

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

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.

Detailed Description

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Conditions

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Healthy

Keywords

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AZD1305 safety pharmacokinetics multiple ascending doses Safety and pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

AZD1305 ER tablet

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

ER tablet, administered as single and repeated doses.

B

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, administered as single and repeated doses.

Interventions

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AZD1305

ER tablet, administered as single and repeated doses.

Intervention Type DRUG

Placebo

Tablet, administered as single and repeated doses.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
* Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator

Exclusion Criteria

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

20 Years

Maximum Eligible Age

70 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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Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Marianne Hartford, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2006-006356-35 (EudraCT No)

Identifier Type: -

Identifier Source: secondary_id

D3190C00004

Identifier Type: -

Identifier Source: org_study_id