A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:8/23/2018
Start Date:April 23, 2012
End Date:June 15, 2012

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

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.

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
We found this trial at
1
site
Trius Investigator Site 001
Overland Park, Kansas 66212
?
mi
from
Overland Park, KS
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