A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01322867
First received: March 23, 2011
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.


Condition Intervention Phase
Healthy
Drug: alprazolam tablet
Drug: alprazolam oral solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug [ Time Frame: Up to 72h ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve from time zero to the last measurable concentration of Test Drug and Reference Drug (AUC(0-tlast)) [ Time Frame: Up to 72h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf)) [ Time Frame: Up to 72h ] [ Designated as safety issue: No ]
  • Time to peak concentration of Test Drug and Reference Drug (Tmax) [ Time Frame: Up to 72h ] [ Designated as safety issue: No ]
  • Half-life of Test Drug and Reference Drug (T1/2) [ Time Frame: Up to 72h ] [ Designated as safety issue: No ]
  • Elimination rate constant (K el) [ Time Frame: Up to 72h ] [ Designated as safety issue: No ]
  • Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity [ Time Frame: Up to 72h ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference Drug Drug: alprazolam tablet
0,25 mg oral tablets given once
Active Comparator: Test Drug Drug: alprazolam oral solution
0,75 mg/ml Oral Solution (Drops) given once

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 and clinical laboratory tests)
  • The BMI - Body Mass Index of the volunteers should be within the range of 18,5 to 24,9 (Dietary Guidelines for Americans) and it may vary up to 15% due to the upper limit (18,5 to 28,63) and total body weight >50kg
  • An informed consent document signed and dated by the subject or a legally acceptable representative. If the subject and/or legally acceptable representative cannot read, then the informed consent document may be signed by an impartial witness
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy)
  • A history of suicidal thoughts, behavior or suicide attempts
  • 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 time of dosing)
  • Known hypersensitivity to alprazolam or any components of the product
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • A positive bHCG exam for women
  • Subjects with myasthenia gravis or acute narrow angle glaucoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322867

Locations
Brazil
ICF - Instituto de Ciencias Farmaceuticas
Aparecida de Goiania, GO, Brazil, 74935-530
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01322867     History of Changes
Other Study ID Numbers: A6131023
Study First Received: March 23, 2011
Last Updated: October 25, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Pfizer:
bioequivalence study
alprazolam
frontal

Additional relevant MeSH terms:
Pharmaceutical Solutions
Alprazolam
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014