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Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation

NCT ID: NCT00947440

Last Updated: 2010-10-21

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.

Detailed Description

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A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Tablet 1 vs. Capsule

Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.

Group Type ACTIVE_COMPARATOR

ABT-072

Intervention Type DRUG

See arm description for more information

Tablet 2 vs. Capsule

Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.

Group Type ACTIVE_COMPARATOR

ABT-072

Intervention Type DRUG

See arm description for more information

Interventions

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ABT-072

See arm description for more information

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overall healthy subjects, non-childbearing females included.

Exclusion Criteria

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Pregnant or breast-feeding female.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Laboratories

Principal Investigators

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Daniel Cohen, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 22384

Waukegan, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M11-056

Identifier Type: -

Identifier Source: org_study_id