Bioavailability Study of Clonazepam Tablets Under Fasting Conditions

Comparative, Randomized, Single-Dose, 2 Way Cross Over Bioavailability Study of Kali's Clonazepam Tablets 1 mg With That of Klonopin Tablets 1 mg in Healthy Adult Subjects Under Fasting Conditions.

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

Study Overview

• Status: Completed
• Conditions: To Determine Bioequivalence Under Fasting Conditions
• Intervention / Treatment: Drug: Clonazepam; Drug: Klonopin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Subjects received the kali formulated products under fasting conditions	Drug: Clonazepam; Tablets, 1 mg, single-dose; Other Names: Klonopin
Active Comparator: B; Subjects received the Roche formulated products under fasting conditions	Drug: Klonopin; tablets, 1 mg, single-dose; Other Names: Clonazepam tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	24 Hours

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: Cetero Research, San Antonio
• Investigators: Principal Investigator: Irwin Plisco, Cetero Research, San Antonio; Study Director: Gary Shillito, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 4, 2008

Study Record Updates

• Last Update Posted (Estimate): April 4, 2008
• Last Update Submitted That Met QC Criteria: April 3, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: bioequivalence, Clonazepam tablets, fasting
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; GABA Modulators; GABA Agents; Anticonvulsants; Clonazepam
• Other Study ID Numbers: B043201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No