You are here

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

Last updated on March 14, 2019

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now