Benzonatate Dose Tolerance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01690975
First received: July 5, 2012
Last updated: September 19, 2012
Last verified: September 2012

July 5, 2012
September 19, 2012
July 2012
August 2012   (final data collection date for primary outcome measure)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01690975 on ClinicalTrials.gov Archive Site
Maximum tolerated dose (MTD): Assessed at end of study [ Time Frame: End of study (2 months) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Cough
  • 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
  • Placebo Comparator: Placebo
    Placebo Control
    Intervention: Drug: Placebo
  • Experimental: Benzonatate
    Benzonatate Active
    Interventions:
    • Drug: Benzonatate - 400 mg
    • Drug: Benzonatate - 600 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
August 2012
August 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01690975
B3551001, BT-10-29
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP