A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
- Registration Number
- NCT01322867
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Drug alprazolam oral solution - Reference Drug alprazolam tablet -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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
Trial Locations
- Locations (1)
ICF - Instituto de Ciencias Farmaceuticas
🇧🇷Aparecida de Goiania, GO, Brazil
ICF - Instituto de Ciencias Farmaceuticas🇧🇷Aparecida de Goiania, GO, Brazil