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

NCT01188031 | Completed Phase 1

• 1 other identifier: R06-0302
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; ALPRAZOLAM; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  72hr

Study Arms (2)

ALPRAZOLAM ORALLY DISINTEGRATING TABLETS

EXPERIMENTAL

ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, single dose

Drug: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG

NIRAVAM TM

ACTIVE COMPARATOR

NIRAVAM TM 2 mg orally disintegrating tablets, single dose

Drug: NIRAVAM TM 2 mg orally disintegrating tablets, single dose

Interventions

ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG DRUG

A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under fasting conditions

Also known as: NIRAVAM

ALPRAZOLAM ORALLY DISINTEGRATING TABLETS

NIRAVAM TM 2 mg orally disintegrating tablets, single dose DRUG

B: Active comparator Subjects received Schwarz Pharma Inc. formulated products under fasting conditions

Also known as: ALPRAZOLAM

NIRAVAM TM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who met the following criteria were included in the study.
• Volunteers who were informed of the nature of the study and who read, reviewed, and signed the informed consent prior to Period I dosing.
• Volunteers who completed the screening process within 28 days prior to Period I dosing.
• Volunteers who were healthy adult men and women 18 years of age or older at the time of dosing.
• Volunteers who had a body mass index (BMI) between 18-32 kg/nr', inclusive, and weighed at least 110 lbs.
• 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.
• 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.)

You may not qualify if:

• Subjects who met any ofthe following criteria were excluded from the study.
• Volunteers who reported receiving any investigational drug within 28 days prior to Period I dosing.
• 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).
• Volunteers whose clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed clinically significant.
• Volunteers who demonstrated a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
• Volunteers who reported a history of allergic response(s) to alprazolam or related drugs.
• Volunteers who reported the use of any systemic prescription medication in the 14 days prior to Period I dosing.
• 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.
• Volunteers who reported a history ofclinically significant allergies including drug allergies.
• Volunteers who reported a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
• Volunteers who reported a history of drug or alcohol abuse addiction or abuse within the past year.
• Volunteers who demonstrated a positive drug abuse screen for this study prior to Period I dose administration.
• Volunteers who currently used tobacco products.
• 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.
• 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

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Interventions

Alprazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• James D. Carlson,, Pharm.D,

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: June 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: August 25, 2010

Record last verified: 2010-08

Locations

US (1)