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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
History of Changes
  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
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 May 21, 2013