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This is a randomized, single-center, open-label, three-period, six-sequence, crossover, comparative study to evaluate the oral bioavailability of single doses of three vapendavir drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral suspension [test drug], and two 132 mg phosphate salt capsules [reference drug]) in healthy volunteers. The study design consists of six dosing sequences. Each sequence comprises 3 periods and each subject is administered one of the three dosing formulations in the first period. A subject receives a different formulation in each of the subsequent periods, so that all subjects receive each formulation. The periods are separated by an approximate 7-day washout.
Owner of Study Record: Vaxart Inc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vapendavir Capsule, 264 mg | Experimental | Vapendavir phosphate salt administered orally as a single dose of two 132 mg hard gelatin capsules |
|
| Vapendavir Tablets, 264 mg | Experimental | Vapendavir free base tablets containing 264 mg of vapendavir |
|
| Vapendavir Oral Suspension, 264 mg | Experimental | Vapendavir free base as a 24 mg/mL oral suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vapendavir 132 mg capsule | Drug |
|
| |
| vapendavir 264 mg tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Relative oral bioavailability, as applicable | Study Day 0 - 17 | |
| Maximum observed plasma concentration (Cmax) | Study Day 0 - 17 | |
| Time at which Cmac was observed (Tmax) | Study Day 0 - 17 | |
| Area under the plasma concentration time curve from time ) to the last measureable plasma concentration (AUC 0-last) | Study Day 0 - 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Novotney-Barry | Aviragen Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aviragen Investigational Site | Saint Paul | Minnesota | 55114 | United States |
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| Drug |
|
|
| vapendavir 24 mg/mL oral suspension | Drug |
|
|
| ID | Term |
|---|---|
| D013607 | Tablets |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
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