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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD1305

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689039

2006-006356-35 (EudraCT No)

D3190C00004

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

AZD1305 ER tablet

Treatment:

Drug: AZD1305

B

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo