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Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681395
First Posted: May 21, 2008
Last Update Posted: September 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
May 19, 2008
May 21, 2008
September 28, 2012
May 2008
August 2008   (Final data collection date for primary outcome measure)
  • Adverse event and safety laboratory assessments [ Time Frame: 7 days ]
  • Pharmacokinetic parameters [ Time Frame: 7 days ]
Adverse event and safety laboratory assessments [ Time Frame: 7 days ]
Complete list of historical versions of study NCT00681395 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 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
Not Provided
To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adverse Events
  • Pharmacokinetic
  • Drug: ABT-143
    once daily for 6 days
  • Drug: ABT-335
    once daily for six days
  • Drug: Rosuvastatin
    Once daily for 6 days
  • Experimental: 1
    ABT-143 capsules 20/135 mg
    Intervention: Drug: ABT-143
  • Active Comparator: 2
    ABT-335 135mg and rosuvastatin 20mg
    Interventions:
    • Drug: ABT-335
    • Drug: Rosuvastatin
  • Experimental: 3
    ABT-143 capsules 5/45mg
    Intervention: Drug: ABT-143
  • Active Comparator: 4
    ABT-335 45mg and rosuvastatin 5mg
    Interventions:
    • Drug: ABT-335
    • Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
Not Provided
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • General good health
  • BMI 19 to 29

Exclusion Criteria:

  • Currently enrolled in another study
  • Females who are pregnant or breastfeeding
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00681395
M10-360
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Torbjörn Lundström, MD AstraZeneca
AstraZeneca
September 2012

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