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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
ICF - Instituto de Ciencias Farmaceuticas
Aparecida de Goiania, GO, 74935-530 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01322867
Pfizer
Completed
A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets

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A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: alprazolam tablet
    0,25 mg oral tablets given once
  • Drug: alprazolam oral solution
    0,75 mg/ml Oral Solution (Drops) given once
  • Active Comparator: Reference Drug
    Intervention: Drug: alprazolam tablet
  • Active Comparator: Test Drug
    Intervention: Drug: alprazolam oral solution
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01322867
A6131023
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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