- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00830024
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
September 1, 2009 updated by: Teva Pharmaceuticals USA
A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Non-fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under non-fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
East Grand Forks, Minnesota, United States, 56721
- PRACS Institute, Ltd.
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- PRACS Institute, Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Screening Demographics: All subjects selected for this study will be healthy non-smoking men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
- Screening procedures: Each subject will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems.
The screening clinical laboratory procedures will include:
- Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
- Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
- HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens;
- Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
- Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, and phencyclidine.
- Serum Pregnancy Screen (female subjects only)
- FSH (to verify postmenopausal status; female subjects only)
If female and:
- is postmenopausal for at least 1 year and has a serum FSH level ≥ 20mIU/mL; or
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Exclusion Criteria:
- Subjects with a recent history of dug or alcohol addiction or abuse.
- Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
- Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.
- Subjects demonstrating positive drug abuse screen when screened for this study.
- Female subjects demonstrating a positive pregnancy screen.
- Female subjects who are currently breast-feeding.
- Subjects with a history of allergic response(s) to alprazolam or related drugs.
- Subjects with a history of clinically significant allergies including drug allergies.
- Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Subjects who currently use or report using tobacco products within 90 days of Period I dose administration.
- Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- Subjects who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
- Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
- Subjects who report an intolerance of direct venipuncture.
- Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Alprazolam (test)
Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
|
1 x 3 mg, single dose non-fasting
Other Names:
|
ACTIVE_COMPARATOR: Xanax XR®
Xanax XR® 3 mg Tablet (test) dosed in first period followed by Alprazolam 3 mg ER Tablet (test) dosed in second period
|
1 x 3 mg, single dose non-fasting
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Concentration
Time Frame: Blood samples collected over 72 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 72 hour period
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time Frame: Blood samples collected over 72 hour period
|
Bioequivalence based on AUC0-inf
|
Blood samples collected over 72 hour period
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time Frame: Blood samples collected over 72 hour period
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 72 hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (ACTUAL)
June 1, 2005
Study Completion (ACTUAL)
June 1, 2005
Study Registration Dates
First Submitted
January 26, 2009
First Submitted That Met QC Criteria
January 26, 2009
First Posted (ESTIMATE)
January 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 11, 2009
Last Update Submitted That Met QC Criteria
September 1, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R05-0167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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