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AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

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ClinicalTrials.gov Identifier: NCT00918398
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : July 30, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance

Condition or disease Intervention/treatment Phase
Healthy Postmenopausal Surgically Sterile Women Drug: AZD1981 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration
Study Start Date : June 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1
AZD1981, 100 mg iv infusion
Drug: AZD1981
100 mg iv infusion, single dose, 4 hours infusion
Experimental: 2
AZD1981, 514 mg oral solution
Drug: AZD1981
514 mg oral solution, single dose
Experimental: 3
AZD1981, 500 mg oral tablet A
Drug: AZD1981
500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose
Experimental: 4
AZD1981, 500 mg oral tablet B
Drug: AZD1981
500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose



Primary Outcome Measures :
  1. PK samples for AZD1981 from both blood and urine [ Time Frame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose. ]

Secondary Outcome Measures :
  1. Safety variables (adverse events and laboratory safety lab) [ Time Frame: Adverese events registered during study and vital signs and ECG at visit 1,2 ,6 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Men or post-menopausal or surgically sterile women, aged 18 to 55 years
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918398


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Elisabeth Eden Quintiles AB, Uppsala, Sweden

Responsible Party: Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
ClinicalTrials.gov Identifier: NCT00918398     History of Changes
Other Study ID Numbers: D9831C00003
EudraCT No. 2009-010964-40
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009