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Bioavailability Study of Clonazepam ODT Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652912
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
Cetero Research, San Antonio
Information provided by:
Par Pharmaceutical, Inc.

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

Condition or disease Intervention/treatment Phase
To Determine Bioequivalence Under Fasting Conditions Drug: Clonazepam Drug: Klonopin Wafers Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : March 2004
Actual Primary Completion Date : April 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Clonazepam

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate and Extent of Absorption [ Time Frame: 24 Hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652912

Sponsors and Collaborators
Par Pharmaceutical, Inc.
Cetero Research, San Antonio
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Principal Investigator: Ali Ziaee Cetero Research, San Antonio
Study Director: Gary Shillito Cetero Research, San Antonio
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Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc. Identifier: NCT00652912    
Other Study ID Numbers: B043204
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: April 2008
Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence, Clonazepam ODT , fasting
Additional relevant MeSH terms:
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Pathologic Processes
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs