Healthy
Conditions
Keywords
bioequivalence study, alprazolam, frontal
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.
Interventions
0,25 mg oral tablets given once
DRUGalprazolam oral solution
0,75 mg/ml Oral Solution (Drops) given once
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Half-life of Test Drug and Reference Drug (T1/2) | Up to 72h |
| 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 |
| Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity | Up to 72h |
| Elimination rate constant (K el) | Up to 72h |
| Time to peak concentration of Test Drug and Reference Drug (Tmax) | Up to 72h |
Countries
Brazil
Outcome results
None listed