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

AstraZeneca94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

AZD1305DRUG

ER tablet, administered as single and repeated doses.

PlaceboDRUG

Tablet, administered as single and repeated doses.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Gothenburg, Sweden

Outcomes

Primary Outcomes

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

Time frame: During the study

Secondary Outcomes

Pharmacokinetic variables

Time frame: During all dosing visits

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.