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Clinical Trials/NCT01091649
NCT01091649CompletedPhase 1

An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation

Abbott1 site in 1 country40 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Abbott
Enrollment
40
Locations
1
Primary Endpoint
Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

A

Active Comparator

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

Intervention: ABT-450 (Drug)

A

Active Comparator

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

Intervention: ritonavir (Drug)

B

Active Comparator

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

Intervention: ABT-450 (Drug)

B

Active Comparator

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

Intervention: ritonavir (Drug)

C

Active Comparator

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

Intervention: ABT-450 (Drug)

C

Active Comparator

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

Intervention: ritonavir (Drug)

D

Active Comparator

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

Intervention: ritonavir (Drug)

D

Active Comparator

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

Intervention: ABT-450 (Drug)

E

Active Comparator

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

Intervention: ritonavir (Drug)

E

Active Comparator

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

Intervention: ABT-450 (Drug)

Outcomes

Primary Outcomes

Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir

Time Frame: 72 hrs post dose

Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir

Time Frame: 72 hrs post dose

Secondary Outcomes

  • To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir(Through 30 days post last dose.)

Investigators

Sponsor
Abbott
Sponsor Class
Industry

Study Sites (1)

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