Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
This study has been completed.
Sponsor:
Teva Pharmaceuticals USA
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00830024
First received: January 26, 2009
Last updated: September 1, 2009
Last verified: September 2009
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Purpose
Detailed Description:
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Alprazolam Extended-Release 3 mg Tablets |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
Official Title: | A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Non-fasting Conditions |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceuticals USA:
Primary Outcome Measures:
- Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
- AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Enrollment: | 36 |
Study Start Date: | June 2005 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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
|
Drug: Alprazolam Extended-Release 3 mg Tablets
1 x 3 mg, single dose non-fasting
|
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
|
Drug: Alprazolam Extended-Release 3 mg Tablets
1 x 3 mg, single dose non-fasting
Other Name: XANAX XR®
|
Detailed Description:
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830024
Locations
United States, Minnesota | |
PRACS Institute, Ltd. | |
East Grand Forks, Minnesota, United States, 56721 | |
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: | James D. Carlson, Pharm. D. | PRACS Institute, Ltd. |
More Information
No publications provided
Keywords provided by Teva Pharmaceuticals USA:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00830024 History of Changes |
Other Study ID Numbers: | R05-0167 |
Study First Received: | January 26, 2009 |
Results First Received: | June 18, 2009 |
Last Updated: | September 1, 2009 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence Healthy Subjects |
Additional relevant MeSH terms:
Alprazolam Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 18, 2012