MedDataX Logo

Assessment of the Effect of Food on ABT-143 Bioavailability

NCT ID: NCT00719693

Last Updated: 2012-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Single-dose, open-label, two-period crossover study of ABT-143

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacokinetic Variables

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Food effect, phase I adverse events

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

ABT-143 under low-fat meal condition

Group Type EXPERIMENTAL

ABT-143 ( rosuvastatin calcium and fenofibric acid )

Intervention Type DRUG

one dose under low-fat meal condition

B

ABT-143 under fasting meal condition

Group Type EXPERIMENTAL

ABT-143 (rosuvastatin calcium and fenofibric acid )

Intervention Type DRUG

one dose under fasting meal condition

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-143 ( rosuvastatin calcium and fenofibric acid )

one dose under low-fat meal condition

Intervention Type DRUG

ABT-143 (rosuvastatin calcium and fenofibric acid )

one dose under fasting meal condition

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-143 fenofibric acid/rosuvastatin calcium

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Torbjörn Lundström, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 9242

Evansville, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M10-442

Identifier Type: -

Identifier Source: org_study_id