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Completed

NCT Number: NCT00957437

Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305

The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Harrow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed, written and dated informed consent prior to any study specific procedures.
  • Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.

Exclusion criteria

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator.
  • Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Treatment and study plan

AZD1305

Drug

Single Oral Dose, ER formulation 1

Primary outcomes

  1. Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma

    Time frame: From predose until 48 hours post last dose

Secondary outcomes

  1. Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight

    Time frame: Frequent safety measurements during the study, from screening period to follow-up

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Open, Single-centre Study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers

Important dates

Study start
2009
Study completion
2009
First posted
Aug 12, 2009
Registry last updated
Nov 26, 2009

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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