Assessment of the Effect of Food on ABT-143 Bioavailability | NCT00719693

Studies
Assessment of the Effect of Food on ABT-143 Bioavailability

NCT00719693

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 28, 2012Estimated

Enrollment

115Actual

Phase

Phase 1

Conditions

Pharmacokinetic Variables

Interventions

ABT-143 ( rosuvastatin calcium and fenofibric acid )
ABT-143 (rosuvastatin calcium and fenofibric acid )

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Not provided

First Submitted Date

Jul 18, 2008

First Submission Date that Met QC Criteria

Jul 21, 2008

First Posted Date

Jul 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2012

Last Update Posted Date

Sep 28, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	ABT-143 under low-fat meal condition	Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )
B	Experimental	ABT-143 under fasting meal condition	Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABT-143 ( rosuvastatin calcium and fenofibric acid )	Drug	one dose under low-fat meal condition	A

Measure	Description	Time Frame
Pharmacokinetics		7 days

Measure	Description	Time Frame
Adverse Events		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-55 years of age (inclusive)
BMI 19 to 29 inclusive

Exclusion Criteria:

Asian ancestry
Concurrent participation in another study
Females pregnant or breastfeeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torbjörn Lundström, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 9242		Evansville	Indiana	47710	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium
C006012	fenofibric acid

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

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Browse Branches

Not provided