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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689403
First received: May 30, 2008
Last updated: December 1, 2010
Last verified: December 2010
  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
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
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:
AZD1305
pharmacokinetics
Properties of different ER formulations

ClinicalTrials.gov processed this record on October 01, 2014