We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689403
First Posted: June 3, 2008
Last Update Posted: December 3, 2010
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.
Information provided by:
AstraZeneca
  Purpose
To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.

Condition Intervention Phase
Healthy Drug: AZD1305 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

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

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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00689403


Locations
United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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
ClinicalTrials.gov Identifier: NCT00689403     History of Changes
Other Study ID Numbers: D3190C00014
First Submitted: May 30, 2008
First Posted: June 3, 2008
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
AZD1305
pharmacokinetics
Properties of different ER formulations