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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Low dose ABT-450 capsule and ritonavir capsules (reference). |
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| B | Active Comparator | Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1) |
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| C | Active Comparator | Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2). |
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| D | Active Comparator | High dose ABT-450 capsule and ritonavir capsules (reference). |
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| E | Active Comparator | High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450 | Drug | Low dose ABT-450 / ritonavir see Arm Description for more information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 72 hrs post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Adebayo Lawal, M.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27781 | Waukegan | Illinois | 60085 | United States |
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| ID | Term |
|---|---|
| C585405 | paritaprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| ritonavir | Drug | ritonavir see Arm Description for more information |
|
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| ABT-450 | Drug | High dose ABT-450 / ritonavir See Arm Description for more information |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |