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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014