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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681395
First received: May 19, 2008
Last updated: September 27, 2012
Last verified: September 2012

May 19, 2008
September 27, 2012
May 2008
August 2008   (final data collection date for primary outcome measure)
  • Adverse event and safety laboratory assessments [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Adverse event and safety laboratory assessments [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00681395 on ClinicalTrials.gov Archive Site
Not Provided
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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
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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adverse Events
  • Pharmacokinetic
  • Drug: ABT-143
    once daily for 6 days
    Other Name: ABT-143
  • Drug: ABT-335
    once daily for six days
    Other Name: ABT-335
  • Drug: Rosuvastatin
    Once daily for 6 days
    Other Name: Rosuvastatin
  • 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681395
M10-360
No
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