Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829426
First received: January 26, 2009
Last updated: June 18, 2009
Last verified: June 2009
  Purpose

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 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 Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence Based on Cmax [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on AUC0-Inf [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on AUC0-t [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]

Enrollment: 32
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
Alprazolam 3mg 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 fasting
Active Comparator: Xanax XR®
Xanax XR® 3 mg Tablet (reference) 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 fasting
Other Name: XANAX XR®

Detailed Description:

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829426

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

ClinicalTrials.gov Identifier: NCT00829426     History of Changes
Other Study ID Numbers: R05-0166
Study First Received: January 26, 2009
Results First Received: June 18, 2009
Last Updated: June 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Alprazolam
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014