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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00689039

Enrollment

Registered

2008-06-03

Start date

2007-04-30

Completion date

2008-07-31

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AZD1305, safety, pharmacokinetics, multiple ascending doses, Safety and pharmacokinetics

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.

Interventions

DRUGAZD1305

ER tablet, administered as single and repeated doses.

DRUGPlacebo

Tablet, administered as single and repeated doses.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight	During the study

Secondary

Measure	Time frame
Pharmacokinetic variables	During all dosing visits

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026