A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT01188057
First received: August 23, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG
Drug: NIRAVAM TM 2 mg orally disintegrating tablets, single dose
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 2 mg Alprazolam Oral Disintegrating Tablets Under Non-fasting Conditions

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 72hr ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS
ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, single dose
Drug: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG
A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under non-fasting conditions
Other Name: NIRAVAM
Active Comparator: NIRAVAM TM
NIRAVAM TM 2 mg orally disintegrating tablets, single dose
Drug: NIRAVAM TM 2 mg orally disintegrating tablets, single dose
B: Active comparator Subjects received Schwarz Pharma Inc. formulated products non-under fasting conditions
Other Name: ALPRAZOLAM

Detailed Description:

Study Type: Interventional Study Design: This was a single-center, randomized, two-way crossover study conducted under non-fasting conditions Official Title: A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets under Non-Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

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

Inclusion Criteria:

Subjects who met the following criteria were included in the study.

  1. Volunteers who were informed of the nature of the study and who read, reviewed, and signed the informed consent prior to Period I dosing.
  2. Volunteers who completed the screening process within 28 days prior to Period I dosing.
  3. Volunteers who were healthy adult men and women 18 years of age or older at the time of dosing.
  4. Volunteers who had a body mass index (BMI) between 18-32 kg/nr', inclusive, and weighed at least 110 lbs.
  5. Volunteers who were healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations form the normal range that were considered clinically relevant by the study physician and investigator were evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
  6. Female volunteers ofpostmenopausal (no menses) status for at least 1 year and has a serum FSH level 2: 30 mlU/mL or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.)

Exclusion Criteria:

Subjects who met any ofthe following criteria were excluded from the study.

  1. Volunteers who reported receiving any investigational drug within 28 days prior to Period I dosing.
  2. Volunteers who reported any presence or history 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 investigator(s).
  3. Volunteers whose clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed clinically significant.
  4. Volunteers who demonstrated a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
  5. Volunteers who reported a history of allergic response(s) to alprazolam or related drugs.
  6. Volunteers who reported the use of any systemic prescription medication in the 14 days prior to Period I dosing.
  7. Volunteers who reported the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
  8. Volunteers who reported a history ofclinically significant allergies including drug allergies.
  9. Volunteers who reported a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  10. Volunteers who reported a history of drug or alcohol abuse addiction or abuse within the past year.
  11. Volunteers who demonstrated a positive drug abuse screen for this study prior to Period I dose administration.
  12. Volunteers who currently used tobacco products.
  13. Volunteers who reported donating greater than 150 mL ofblood within 28 days prior to Period I dosing. All subjects were advised not to donate blood for four weeks after completing the study.
  14. Volunteers who donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects were advised not to donate plasma for four weeks after completing the study
  15. Volunteers who demonstrated a positive pregnancy screen (females only).
  16. Volunteers who were currently pregnant or breastfeeding (females only).
  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: NCT01188057

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: James D. Carlson,, Pharm.D, PRACS Institute, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT01188057     History of Changes
Other Study ID Numbers: R06-0303
Study First Received: August 23, 2010
Last Updated: August 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
ALPRAZOLAM
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 September 16, 2014