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Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers

NCT02207699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2014-08-04

No results posted yet for this study

Summary

The primary objective of this study is to determine the effects of benzonatate (200 mg and 800 mg) on the QT interval following single dose oral administration at each time point post-dose.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Benzonatate 200 mg

2 benzonatate 100 mg perles and 6 placebo perles give by mouth once

DRUG

Benzonatate 800 mg

8 benzonatate 100 mg perles given by mouth once

DRUG

Moxifloxacin 400 mg

1 moxifloxacin 400 mg tablet given by mouth once

DRUG

Placebo

8 placebo perles given by mouth once

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02207699 on ClinicalTrials.gov