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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: alprazolam tablet
* Drug: alprazolam oral solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference Drug<br> | Drug: alprazolam tablet<br>* 0,25 mg oral tablets given once<br>|
| Active Comparator: Test Drug<br> | Drug: alprazolam oral solution<br>* 0,75 mg/ml Oral Solution (Drops) given once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug |  | Up to 72h | 
| 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)) |  | Up to 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf)) |  | Up to 72h | 
| Time to peak concentration of Test Drug and Reference Drug (Tmax) |  | Up to 72h | 
| Half-life of Test Drug and Reference Drug (T1/2) |  | Up to 72h | 
| Elimination rate constant (K el) |  | Up to 72h | 
| Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity |  | Up to 72h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence study, alprazolam, frontal