Benzonatate Dose Tolerance Study

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690975
• Other study ID #: B3551001
• Secondary ID: BT-10-29
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2012
• Last updated: September 19, 2012
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Placebo
Placebo - single dose at start of each treatment period
• Benzonatate - 400 mg
Benzonatate - 400 mg single dose
• Benzonatate - 600 mg
Benzonatate - 600 mg single dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose	No
Primary	Plasma Decay Half-Life (t1/2)		0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose	No
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)		0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose	No
Secondary	Maximum tolerated dose (MTD): Assessed at end of study		End of study (2 months)	No

External Links

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