Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305 (2007-005765-38)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1305

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689403

D3190C00014

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Part A: 2x2 crossover

Experimental group

Description:

4 different AZD1305 ER formulations

Treatment:

Drug: AZD1305

Drug: AZD1305

Part B: 3x3 crossover

Experimental group

Description:

2 different AZD1305 ER formulations and a reference formulation

Treatment:

Drug: AZD1305

Drug: AZD1305