Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TR701-114 | Other Identifier | TriusRX Unique ID |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.
Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR-701 FA with PSE | Experimental | TR-701 FA 200 mg oral with PSE |
|
| TR-701 FA Placebo with PSE | Placebo Comparator | TR-701 FA Placebo 200 mg oral with PSE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 FA with PSE | Drug | TR-701 FA Oral 200 mg oral with PSE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo | 13 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe G Prokocimer, MD | Trius Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trius Investigator Site 001 | Overland Park | Kansas | 66212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29899212 | Result | Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers. J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150. | |
| 23612197 | Derived | Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TR-701 FA Placebo with PSE | Other | TR-701 FA Placebo Oral 200 mg with PSE |
|