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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1305; Drug: Placebo

• Registration Number: NCT00689039
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-01
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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Exclusion Criteria

• ECG findings outside normal range
• Potassium outside normal reference values

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	AZD1305	AZD1305 ER tablet
B	Placebo	Placebo tablet

Primary Outcome Measures

Name	Time	Method
Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight	During the study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	During all dosing visits

Trial Locations

Locations (1)

Research Site; 🇸🇪 Göteborg, Sweden