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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Adverse Events
Pharmacokinetic Variables
 Drug: ABT-143
Drug: ABT-335 and rosuvastatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: August 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ABT-143 15/135mg
 Drug: ABT-143
once
Other Name: ABT-143
Active Comparator: B
ABT-335 135mg and rosuvastatin 15mg
 Drug: ABT-335 and rosuvastatin
once
Other Name: ABT-335 and rosuvastatin

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Condition of good health

Exclusion Criteria:

  • Currently enrolled in another study
  • Females who are pregnant or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728780

Locations
United States, Indiana
Site Reference ID/Investigator# 11101
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00728780     History of Changes
Other Study ID Numbers: M10-586
Study First Received: August 1, 2008
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Adverse events
Pharmacokinetic variables

Additional relevant MeSH terms:
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013