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
  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:


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
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: 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 August 28, 2014