Benzonatate Dose Tolerance Study

Pfizer

Status and phase: Completed; Phase 1

Conditions: Cough

Treatments: Drug: Placebo; Drug: Benzonatate - 600 mg; Drug: Benzonatate - 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01690975

BT-10-29

B3551001

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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9 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Control

Treatment:

Drug: Placebo

Benzonatate

Experimental group

Description:

Benzonatate Active

Treatment:

Drug: Benzonatate - 600 mg

Drug: Benzonatate - 400 mg