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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689403
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : December 3, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1305 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Two-part, Randomised, Open, Single-centre, Crossover Study to Evaluate Different Extended-release Formulations of AZD1305 When Given as Single Oral Doses to Healthy Male Volunteers
Study Start Date : February 2008
Primary Completion Date : July 2008
Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: Part A: 2x2 crossover
4 different AZD1305 ER formulations
Drug: AZD1305
Extended release capsules, oral single doses
Experimental: Part B: 3x3 crossover
2 different AZD1305 ER formulations and a reference formulation
Drug: AZD1305
Extended release capsules, oral single doses

Primary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: During all dosing visits ]

Secondary Outcome Measures :
  1. Adverse events, ECG, safety laboratory, vital signs, physical examination [ Time Frame: During the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00689403

United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
Study Director: Helen Lunde, MD AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Daniel Bradford, MD, MA, MBBS, DCPSA PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom

Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca Identifier: NCT00689403     History of Changes
Other Study ID Numbers: D3190C00014
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Properties of different ER formulations