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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: August 10, 2009
Last updated: November 25, 2009
Last verified: November 2009
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.

Condition Intervention Phase
Drug: AZD1305
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma [ Time Frame: From predose until 48 hours post last dose ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: August 2009
Study Completion Date: November 2009
Arms Assigned Interventions
Experimental: Part A: 3 way crossover
AZD1305: ER test formulation 1 (w/wo food) and reference formulation
Drug: AZD1305
Single Oral Dose, ER formulation 1
Experimental: Part B1: single arm
AZD1305: ER test formulation 1
Drug: AZD1305
ER formulation 1, bid for 5 days
Experimental: Part B2: 3 way crossover
AZD1305: ER test formulation 2 (w/wo food) and reference formulation
Drug: AZD1305
Single Oral Dose, ER formulation 2


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00957437

United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
Study Director: Helen Lunde AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Klaus Francke PAREXEL Early Phase Clinical Unit, London UK.
  More Information

Responsible Party: MSD, AstraZeneca Identifier: NCT00957437     History of Changes
Other Study ID Numbers: D3190C00016
Study First Received: August 10, 2009
Last Updated: November 25, 2009

Keywords provided by AstraZeneca:
Phase 1
healthy volunteer
AZD1305 processed this record on May 25, 2017