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

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Abbott

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: ritonavir
Drug: ABT-450

Study type

Interventional

Funder types

Industry

Identifiers

NCT01091649
M10-797

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

40 participants in 5 patient groups

A
Active Comparator group
Description:
Low dose ABT-450 capsule and ritonavir capsules (reference).
Treatment:
Drug: ABT-450
Drug: ABT-450
Drug: ritonavir
B
Active Comparator group
Description:
Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
Treatment:
Drug: ABT-450
Drug: ABT-450
Drug: ritonavir
C
Active Comparator group
Description:
Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
Treatment:
Drug: ABT-450
Drug: ABT-450
Drug: ritonavir
D
Active Comparator group
Description:
High dose ABT-450 capsule and ritonavir capsules (reference).
Treatment:
Drug: ABT-450
Drug: ABT-450
Drug: ritonavir
E
Active Comparator group
Description:
High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
Treatment:
Drug: ABT-450
Drug: ABT-450
Drug: ritonavir

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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