Evaluate Different Extended-Release (ER) Tablets/Capsules of AZD1305 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00689403

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AZD1305	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part A: 2x2 crossover: Experimental 4 different AZD1305 ER formulations	Drug: AZD1305 Extended release capsules, oral single doses
Part B: 3x3 crossover: Experimental 2 different AZD1305 ER formulations and a reference formulation	Drug: AZD1305 Extended release capsules, oral single doses

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689403

Locations

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:	AstraZeneca ( Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids )
Study ID Numbers:	D3190C00014
Study First Received:	May 30, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00689403
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

AZD1305
pharmacokinetics
Properties of different ER formulations

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009