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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Adverse Events
Pharmacokinetic
 Drug: ABT-143
Drug: ABT-335
Drug: Rosuvastatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability 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 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 ]

Enrollment: 64
Study Start Date: May 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ABT-143 capsules 20/135 mg
 Drug: ABT-143
once daily for 6 days
Other Name: ABT-143
Active Comparator: 2
ABT-335 135mg and rosuvastatin 20mg
 Drug: ABT-335
once daily for six days
Other Name: ABT-335
Drug: Rosuvastatin
Once daily for 6 days
Other Name: Rosuvastatin
Experimental: 3
ABT-143 capsules 5/45mg
 Drug: ABT-143
once daily for 6 days
Other Name: ABT-143
Active Comparator: 4
ABT-335 45mg and rosuvastatin 5mg
 Drug: ABT-335
once daily for six days
Other Name: ABT-335
Drug: Rosuvastatin
Once daily for 6 days
Other Name: Rosuvastatin

  Eligibility

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

Inclusion Criteria:

  • General good health
  • BMI 19 to 29

Exclusion Criteria:

  • Currently enrolled in another study
  • Females who are pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681395

Locations
United States, Florida
Site Reference ID/Investigator# 8089
Orlando, Florida, United States, 32809
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00681395     History of Changes
Other Study ID Numbers: M10-360
Study First Received: May 19, 2008
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

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 23, 2013