Healthy Subjects Clinical Trial
Official title:
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA
Verified date | August 2018 |
Source | Trius Therapeutics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 15, 2012 |
Est. primary completion date | June 15, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Male or female subjects between 18 and 45 years of age, inclusive - Healthy males and females with no clinically significant abnormalities identified by a detailed medical history - Body mass index = 19.0 kg/m2 and = 31.0 kg/m2 Exclusion Criteria: - Systolic blood pressure > 130 mmHg or < 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1 - Diastolic blood pressure > 90 mmHg or < 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1 - Heart rate > 90 bpm or < 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day - Known allergy or hypersensitivity to PSE |
Country | Name | City | State |
---|---|---|---|
United States | Trius Investigator Site 001 | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
Trius Therapeutics LLC |
United States,
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). pii: E150. doi: 10.3390/jcm7060150. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic Blood Pressure | To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo | 13 days |
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