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

August 23, 2010 updated by: Actavis Inc.

A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets Under Fasting Conditions

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 fasting conditions.

Study Overview

Detailed Description

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

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Study Type

Interventional

Enrollment (Actual)

40

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

    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • 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:

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).

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 ORALLY DISINTEGRATING TABLETS
ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, single dose
A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under fasting conditions
Other Names:
  • NIRAVAM
ACTIVE_COMPARATOR: NIRAVAM TM
NIRAVAM TM 2 mg orally disintegrating tablets, single dose
B: Active comparator Subjects received Schwarz Pharma Inc. formulated products under fasting conditions
Other Names:
  • ALPRAZOLAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate and Extend of Absorption
Time Frame: 72hr
72hr

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, 2006

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (ESTIMATE)

August 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 23, 2010

Last Verified

August 1, 2010

More Information

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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