Full Text View
Tabular View
No Study Results Posted
Related Studies
Fed Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg
This study has been completed.
First Received: March 30, 2008   Last Updated: March 31, 2008   History of Changes
Sponsored by: Mylan Pharmaceuticals
Information provided by: Mylan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00650299
  Purpose

The objective of this study was to investigate the bioequivalence of Mylan's alprazolam Extended-release 3 mg tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered under fed conditions.


Condition Intervention Phase
Healthy
Drug: Alprazolam Extended-release Tablets 3 mg
Drug: Xanax XR® Tablets 3 mg
Phase I

Drug Information available for: Alprazolam
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title: Single-Dose Food In Vivo Bioequivalence Study of Alprazolam Extended-Release Tablets (3 mg; Mylan) to Xanax XR® Tablets (3 mg; Pharmacia & Upjohn) in Healthy Volunteers

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Alprazolam Extended-release Tablets 3 mg
Drug: Alprazolam Extended-release Tablets 3 mg
3mg, single dose fed
2: Active Comparator
Xanax XR® Tablets 3 mg
Drug: Xanax XR® Tablets 3 mg
3mg, single dose fed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.

    1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, the HCG pregnancy test should be given within 24 hours prior to dosing of each study period. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
    2. Women of childbearing potential must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:

      1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
      2. barrier methods containing or used in conjunction with a spermicidal agent, or
      3. surgical sterilization
    3. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:

      (1) postmenopausal with an absence of menses for at least one (1) year, or (2) bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or (3) total hysterectomy

    4. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. Males must also use a spermicide containing barrier method of contraception to prevent the pregnancy of their sexual partners. These stipulations should be documented in the informed consent form. 3. Weight: At least 60 kg (132 lbs) for men and 24 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B, Hepatitis C and HIV tests, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

  • 1. Institutionalized subjects will not be used. 2. Social Habits:

    1. Use of any tobacco products within 1 year of the start of the study.
    2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within 24 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. A positive test for any drug included in the urine drug screen.
    6. History of drug and/or alcohol abuse. 3. Medications:
    1. Use of any prescription or over-the-counter (OTC) medications within 14 days prior to the initial dose of study medication.
    2. Use of any hormonal contraceptives and hormone replacement therapy within 3 months prior to study medication dosing.
    3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.

      4. Diseases:

    1. History of any significant chronic disease and/or hepatitis.
    2. Acute illness at the time of either the pre-study medical evaluation or dosing.
    3. A positive HIV, Hepatitis B or Hepatitis C test.

      5. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.

      7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.

      8. Allergy or hypersensitivity to alprazolam, other benzodiazepines, lactose, magnesium stearate, colloidal silicon dioxide, hypromellose or D & C Yellow No. 10. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.

      10. History of acute narrow angle glaucoma 11. Consumption of grapefruit or any grapefruit containing products within 7 days of drug administration.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650299

Locations
United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management )
Study ID Numbers: ALPR-0467
Study First Received: March 30, 2008
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00650299     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Alprazolam
Hypnotics and Sedatives
Psychotropic Drugs
Central Nervous System Depressants
Anti-Anxiety Agents
Healthy

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

ClinicalTrials.gov processed this record on May 07, 2009