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

NCT01577459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-08-21

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

TR-701 FA with PSE

TR-701 FA Oral 200 mg oral with PSE

OTHER

TR-701 FA Placebo with PSE

TR-701 FA Placebo Oral 200 mg with PSE

Sponsors & Collaborators

  • Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Philippe G Prokocimer, MD · Trius Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-23
Primary Completion
2012-06-15
Completion
2012-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577459 on ClinicalTrials.gov