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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322867
• Other study ID #: A6131023
• Status: Completed
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• alprazolam tablet
0,25 mg oral tablets given once
• alprazolam oral solution
0,75 mg/ml Oral Solution (Drops) given once

Locations

Country	Name	City	State
Brazil	ICF - Instituto de Ciencias Farmaceuticas	Aparecida de Goiania	GO

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug		Up to 72h
Primary	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	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
Secondary	Time to peak concentration of Test Drug and Reference Drug (Tmax)		Up to 72h
Secondary	Half-life of Test Drug and Reference Drug (T1/2)		Up to 72h
Secondary	Elimination rate constant (K el)		Up to 72h
Secondary	Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity		Up to 72h

External Links

•   To obtain contact information for a study center near you, click here.