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Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450

NCT ID: NCT01091649

Last Updated: 2010-12-21

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-04-30

Brief Summary

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The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.

Detailed Description

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This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.

Conditions

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Healthy

Keywords

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Pharmacokinetics, Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

Low dose ABT-450 capsule and ritonavir capsules (reference).

Group Type ACTIVE_COMPARATOR

ABT-450

Intervention Type DRUG

Low dose ABT-450 / ritonavir see Arm Description for more information

ritonavir

Intervention Type DRUG

ritonavir see Arm Description for more information

B

Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)

Group Type ACTIVE_COMPARATOR

ABT-450

Intervention Type DRUG

Low dose ABT-450 / ritonavir see Arm Description for more information

ritonavir

Intervention Type DRUG

ritonavir see Arm Description for more information

C

Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).

Group Type ACTIVE_COMPARATOR

ABT-450

Intervention Type DRUG

Low dose ABT-450 / ritonavir see Arm Description for more information

ritonavir

Intervention Type DRUG

ritonavir see Arm Description for more information

D

High dose ABT-450 capsule and ritonavir capsules (reference).

Group Type ACTIVE_COMPARATOR

ritonavir

Intervention Type DRUG

ritonavir see Arm Description for more information

ABT-450

Intervention Type DRUG

High dose ABT-450 / ritonavir See Arm Description for more information

E

High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)

Group Type ACTIVE_COMPARATOR

ritonavir

Intervention Type DRUG

ritonavir see Arm Description for more information

ABT-450

Intervention Type DRUG

High dose ABT-450 / ritonavir See Arm Description for more information

Interventions

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ABT-450

Low dose ABT-450 / ritonavir see Arm Description for more information

Intervention Type DRUG

ritonavir

ritonavir see Arm Description for more information

Intervention Type DRUG

ABT-450

High dose ABT-450 / ritonavir See Arm Description for more information

Intervention Type DRUG

Other Intervention Names

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ABT-538, ritonavir, Norvir

Eligibility Criteria

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Inclusion Criteria

* Overall healthy subjects
* Non-childbearing potential females included

Exclusion Criteria

* Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* 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 with the 6-month period prior to study drug administration
* Abnormal screening laboratory results that are considered clinically significant by the investigator
* Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
* Previous exposure to ABT-450
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

Principal Investigators

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Adebayo Lawal, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 27781

Waukegan, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M10-797

Identifier Type: -

Identifier Source: org_study_id