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

Viatris

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: alprazolam oral solution

Drug: alprazolam tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01322867

A6131023

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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