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.

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. Identifier: NCT00728780
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Adverse Events Pharmacokinetic Variables Drug: ABT-143 Drug: ABT-335 and rosuvastatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2008
Actual Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
ABT-143 15/135mg
Drug: ABT-143
Active Comparator: B
ABT-335 135mg and rosuvastatin 15mg
Drug: ABT-335 and rosuvastatin

Primary Outcome Measures :
  1. Adverse events and safety laboratory assessments [ Time Frame: 7 days ]
  2. Pharmacokinetic parameters [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed informed consent
  • Condition of good health

Exclusion Criteria:

  • Currently enrolled in another study
  • Females who are pregnant or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00728780

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

Responsible Party: AstraZeneca Identifier: NCT00728780     History of Changes
Other Study ID Numbers: M10-586
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by AstraZeneca:
Adverse events
Pharmacokinetic variables

Additional relevant MeSH terms:
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors