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Study of an Extended Release (ER) Tablet, Single and Repeated Dosing

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ClinicalTrials.gov Identifier: NCT00689039
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1305 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj
Study Start Date : April 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: A
AZD1305 ER tablet
 Drug: AZD1305
ER tablet, administered as single and repeated doses.
Placebo Comparator: B
Placebo tablet
 Drug: Placebo
Tablet, administered as single and repeated doses.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight [ Time Frame: During the study ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: During all dosing visits ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
  • Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator

Exclusion Criteria:

  • ECG findings outside normal range
  • Potassium outside normal reference values
Contacts and Locations
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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): NCT00689039


Locations
Sweden
Research Site
Göteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Helen Lunde, MD AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Marianne Hartford, MD, PhD AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
More Information
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Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca
ClinicalTrials.gov Identifier: NCT00689039     History of Changes
Other Study ID Numbers: D3190C00004
2006-006356-35 (EudraCT No)
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
AZD1305
safety
pharmacokinetics
multiple ascending doses
Safety and pharmacokinetics