Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 30, 2008
Last updated: December 1, 2010
Last verified: December 2010
To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.

Condition Intervention Phase
Drug: AZD1305
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, ECG, safety laboratory, vital signs, physical examination [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca Identifier: NCT00689403     History of Changes
Other Study ID Numbers: D3190C00014 
Study First Received: May 30, 2008
Last Updated: December 1, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Properties of different ER formulations processed this record on October 27, 2016