A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions
Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG (Drug); NIRAVAM TM 2 mg orally disintegrating tablets, single dose (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Actavis Inc. Official(s) and/or principal investigator(s):
James D. Carlson,, Pharm.D,, Principal Investigator, Affiliation: PRACS Institute, Ltd.
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 non-fasting conditions.
Clinical Details
Official title: A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets Under Non-fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Rate and Extend of Absorption
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
PRACS Institute, Ltd., Fargo, North Dakota 58102, United States
Additional Information
ALPRAZOLAM
Starting date: July 2006
Last updated: August 23, 2010
|
