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

NCT01322867 | Completed Phase 4

• 1 other identifier: A6131023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

bioequivalence study; alprazolam; frontal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (2)

Reference Drug

ACTIVE COMPARATOR

Drug: alprazolam tablet

Test Drug

ACTIVE COMPARATOR

Drug: alprazolam oral solution

Interventions

alprazolam tablet DRUG

0,25 mg oral tablets given once

Reference Drug

alprazolam oral solution DRUG

0,75 mg/ml Oral Solution (Drops) given once

Test Drug

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

ICF - Instituto de Ciencias Farmaceuticas

Aparecida de Goiânia, Goiás, 74935-530, Brazil

Location

Related Links

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

MeSH Terms

Interventions

Alprazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 25, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

BR (1)