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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-108 | Other Identifier | TriusRX Unique ID |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.
Subjects will receive the following treatments in a crossover design:
Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;
Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;
Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t, and AUC0-inf.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| free acid | Experimental | TR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700) |
|
| di-sodium phosphate salt | Experimental | One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 di-sodium phosphate salt | Drug | One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics and relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule after single doses in normal healthy adult subjects | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Carter, MD | Covance CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Austin | Texas | 78752 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23926058 | Derived | Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7. |
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| TR-701 free acid phosphate | Drug | One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700) |
|