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Benzonatate Dose Tolerance Study

NCT ID: NCT01690975

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo - single dose at start of each treatment period

Benzonatate

Benzonatate Active

Group Type EXPERIMENTAL

Benzonatate - 400 mg

Intervention Type DRUG

Benzonatate - 400 mg single dose

Benzonatate - 600 mg

Intervention Type DRUG

Benzonatate - 600 mg single dose

Interventions

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Placebo

Placebo - single dose at start of each treatment period

Intervention Type DRUG

Benzonatate - 400 mg

Benzonatate - 400 mg single dose

Intervention Type DRUG

Benzonatate - 600 mg

Benzonatate - 600 mg single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3551001&StudyName=Benzonatate%20Dose%20Tolerance%20Study

To obtain contact information for a study center near you, click here.

Other Identifiers

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BT-10-29

Identifier Type: -

Identifier Source: secondary_id

B3551001

Identifier Type: -

Identifier Source: org_study_id