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Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00728780
First received: August 1, 2008
Last updated: September 27, 2012
Last verified: September 2012

August 1, 2008
September 27, 2012
August 2008
September 2008   (final data collection date for primary outcome measure)
  • Adverse events and safety laboratory assessments [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00728780 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.
Not Provided

The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adverse Events
  • Pharmacokinetic Variables
  • Drug: ABT-143
    once
    Other Name: ABT-143
  • Drug: ABT-335 and rosuvastatin
    once
    Other Name: ABT-335 and rosuvastatin
  • Experimental: A
    ABT-143 15/135mg
    Intervention: Drug: ABT-143
  • Active Comparator: B
    ABT-335 135mg and rosuvastatin 15mg
    Intervention: Drug: ABT-335 and rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • Condition of good health

Exclusion Criteria:

  • Currently enrolled in another study
  • Females who are pregnant or breast feeding
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00728780
M10-586
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Torbjörn Lundström AstraZeneca
AstraZeneca
September 2012

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