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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1305

• Registration Number: NCT00689403
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• 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: Male
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A: 2x2 crossover	AZD1305	4 different AZD1305 ER formulations
Part B: 3x3 crossover	AZD1305	2 different AZD1305 ER formulations and a reference formulation

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	During all dosing visits

Secondary Outcome Measures

Name	Time	Method
Adverse events, ECG, safety laboratory, vital signs, physical examination	During the study

Trial Locations

Locations (1)

Research Site; 🇬🇧 Harrow, United Kingdom