Bioavailability Study of Clonazepam ODT Under Fasting Conditions - Full Text View

Sponsor:	Par Pharmaceutical, Inc.
Collaborator:	Gatway Medical Research, Inc
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00652912

Purpose

To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg ODT

Condition	Intervention	Phase
To Determine Bioequivalence Under Fasting Conditions	Drug: Clonazepam Drug: Klonopin Wafers	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Comparative, Randomized, Single-Dose, Bioavailability Study of Kali's Clonazepam ODT 1 mg With That of Klonopin Wafers 1 mg ODT in Healthy Adult Subjects Under Fasting Conditions.

Resource links provided by NLM:

Drug Information available for: Clonazepam

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Rate and Extent of Absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	March 2004
Study Completion Date:	May 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Subjects received the Kali formulated products under fasting conditions	Drug: Clonazepam ODT, 1 mg Other Name: Klonopin Wafers
Active Comparator: B Subjects received the Roche's product under fasting conditions	Drug: Klonopin Wafers ODT, 1 mg Other Name: Clonazepam ODT

Detailed Description:

To compare the single -dose bioavailability of kali's Clonazepam ODT 1 mg with that of Klonopin Wafers 1 mg ODT by Roche pharmaceuticals following a single oral dose under fasting conditions.

Eligibility

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

Criteria

Inclusion Criteria:

All subjects selected for this study will be alt least 18 years of age.Females must be of non- childbearing potential (postmenopausal for alt least 6 months or surgically sterile)
Each subject shall be given a general physical examination within 28 days of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
Each female subject will be given a serum pregnancy test as part of the pre-study process.
At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trail for clinical laboratory.
Clinical laboratory measurements will include the following:
Hematology: hemoglobin, hematocrit, red blood cell count (with differential)
Clinical Chemistry: creatinine, BUN, glucose, SGOT/ AST, SGPT/ALT, bilirubin, and alkaline phosphate.
Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood and cells.
HIV Screen: (Pre-study only)
Hepatitis-B, C Screen: (Pre-study only)
Drugs of Abuse Screen: (Pre-study at check -in each dosing period)
Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.

Exclusion Criteria:

Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis epilepsy, asthma, (during pat 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
Subjects whose clinical laboratory test values are outside the normal range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
Subjects who have a history of allergic response to the class of drug being tested should excluded form the study.
All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and check in each dosing period. Subjects found to have urine concentration of any of the tested drugs will not be allowed to participate.
Subjects should not have donated blood and/plasma for at least thirty (30) days prior to the first dosing of the study
Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
Female subjects with childbearing potential will not be allowed to participate.
All female subjects will be screened for pregnancy at check in each study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652912

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Gatway Medical Research, Inc

Investigators

Principal Investigator:	Ali Ziaee	Cetero Research, San Antonio
Study Director:	Gary Shillito	Cetero Research, San Antonio

More Information

No publications provided

Responsible Party:	Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00652912 History of Changes
Other Study ID Numbers:	B043204
Study First Received:	April 1, 2008
Last Updated:	April 3, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence, Clonazepam ODT , fasting

Additional relevant MeSH terms:

Disease
Pathologic Processes
Clonazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012