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Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00771979
First received: October 14, 2008
Last updated: June 17, 2009
Last verified: June 2009
History of Changes

October 14, 2008
June 17, 2009
November 2008
Not Provided
To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation. [ Time Frame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00771979 on ClinicalTrials.gov Archive Site
  • To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events. [ Time Frame: From time of consent to last visit. ] [ Designated as safety issue: Yes ]
  • An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530 [ Time Frame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Relative Bioavailability of Phase II and Phase III Formulations of AZD0530
A Phase I, Randomised, Open-Label, Cross-Over, Single Centre Study in Healthy Volunteers to Determine the Relative Bioavailability of the Phase III Tablet Formulation to the Phase II Tablet Formulation of AZD0530

The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: AZD0530
    of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.
  • Drug: AZD0530
    Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.
Experimental: 1
Interventions:
  • Drug: AZD0530
  • Drug: AZD0530
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2009
Not Provided

Inclusion Criteria:

  • Female subjects must be of Non- child-bearing potential
  • Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg

Exclusion Criteria:

  • Presence of any clinically significant illness
  • Abnormal vital signs
  • History of any conditions that may put the subject at risk by participating in the study
  • Participation in another clinical study.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00771979
D8180C00033
No
Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Raj Chetty, MD AstraZeneca, Clinical Pharmacology Unit, Alderley Park
Study Director: Mary Stuart, MD AstraZeneca,Parklands, Alderley Park
AstraZeneca
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP