NCT01690975

Benzonatate Dose Tolerance Study

A Phase I, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Tolerability of Benzonatate Following Single Dose Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, third party blind, placebo controlled, dose escalation study of benzonatate following single dose administration. The primary oobjective is to assess the safety and tolerability of increasing oral doses of benzonatate following single dose administration in healthy male and female subjects.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Placebo	Placebo - single dose at start of each treatment period
DRUG	Benzonatate - 400 mg	Benzonatate - 400 mg single dose
DRUG	Benzonatate - 600 mg	Benzonatate - 600 mg single dose

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-09-24
• Last updated: 2012-09-24

Locations

1 site across 1 country: United States