Bioavailability Study of Clonazepam ODT Under Fasting Conditions

• ClinicalTrials.gov Identifier: NCT00652912
• Recruitment Status: Completed
• First Posted: April 4, 2008
• Last Update Posted: April 4, 2008
• Sponsor: Par Pharmaceutical, Inc.
• Collaborator: Cetero Research, San Antonio
• Information provided by: Par Pharmaceutical, Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Cetero Research, San Antonio

Investigators

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

More Information

• Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
• ClinicalTrials.gov Identifier: NCT00652912
• Other Study ID Numbers: B043204
• First Posted: April 4, 2008
• Last Update Posted: April 4, 2008
• Last Verified: April 2008

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence, Clonazepam ODT , fasting

Additional relevant MeSH terms:

Disease; Pathologic Processes; Clonazepam; Anticonvulsants; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs