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Single Ascending Dose Study (SAD) iv Formulation

NCT ID: NCT00688831

Last Updated: 2010-12-02

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

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body (how it is taken up into the body, distributed around the body and disappears from the body

Detailed Description

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Conditions

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Healthy

Keywords

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AZD1305 SAD safety pharmcokinetics Safety and tolerability

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 solution for iv infusion

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Solution for iv infusion , single dose

B

NaCl solution for iv infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl solution for iv infusion, single dose

Interventions

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AZD1305

Solution for iv infusion , single dose

Intervention Type DRUG

Placebo

NaCl solution for iv infusion, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* BIM 19-30 kg/m2

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

Marianne Hartford, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göeborg, Sweden

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D3190C00002

Identifier Type: -

Identifier Source: org_study_id