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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00681395
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Adverse Events; Pharmacokinetic	Drug: ABT-143; Drug: ABT-335; Drug: Rosuvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ABT-143 capsules 20/135 mg	Drug: ABT-143; once daily for 6 days
Active Comparator: 2 ABT-335 135mg and rosuvastatin 20mg	Drug: ABT-335; once daily for six days; Drug: Rosuvastatin; Once daily for 6 days
Experimental: 3 ABT-143 capsules 5/45mg	Drug: ABT-143; once daily for 6 days
Active Comparator: 4 ABT-335 45mg and rosuvastatin 5mg	Drug: ABT-335; once daily for six days; Drug: Rosuvastatin; Once daily for 6 days

Outcome Measures

Primary Outcome Measures

1. Adverse event and safety laboratory assessments [7 days]

2. Pharmacokinetic parameters [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 8089	Orlando	Florida	United States	32809

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Torbjörn Lundström, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00681395
• Other Study ID Numbers: M10-360
• First Posted: May 21, 2008
• Last Update Posted: Sep 28, 2012
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Rosuvastatin Calcium

Study Results

No Results Posted as of Sep 28, 2012