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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: AZD1305 Drug: Placebo | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: A
AZD1305 ER tablet
|
Drug: AZD1305
ER tablet, administered as single and repeated doses.
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Placebo Comparator: B
Placebo tablet
|
Drug: Placebo
Tablet, administered as single and repeated doses.
|
- Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight [ Time Frame: During the study ]
- Pharmacokinetic variables [ Time Frame: During all dosing visits ]

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Ages Eligible for Study: | 20 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Sweden | |
Research Site | |
Göteborg, Sweden |
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 |
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 |