Clinical trial NCT01322867: A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: bioequivalence study
alprazolam
frontal
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug
timeFrame: Up to 72h
measure: 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))
timeFrame: Up to 72h
Secondary outcomes:
measure: Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf))
timeFrame: Up to 72h
measure: Time to peak concentration of Test Drug and Reference Drug (Tmax)
timeFrame: Up to 72h
measure: Half-life of Test Drug and Reference Drug (T1/2)
timeFrame: Up to 72h
measure: Elimination rate constant (K el)
timeFrame: Up to 72h
measure: Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity
timeFrame: Up to 72h
Other outcomes:
Locations:
city: Aparecida de Goiania
country: Brazil
facility: ICF - Instituto de Ciencias Farmaceuticas
state: GO
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: