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OpenTrials
Completed

NCT Number: NCT00689039

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

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.

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Key information

Conditions

Healthy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1305

Drug

ER tablet, administered as single and repeated doses.

Placebo

Drug

Tablet, administered as single and repeated doses.

Primary outcomes

  1. Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight

    Time frame: During the study

Secondary outcomes

  1. Pharmacokinetic variables

    Time frame: During all dosing visits

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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