Bioavailability Study of Clonazepam ODT Under Fasting Conditions

NCT00652912 | Completed Phase 1

• 1 other identifier: B043204
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

bioequivalence, Clonazepam ODT , fasting

Outcome Measures

Primary Outcomes (1)

• Rate and Extent of Absorption

  24 Hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received the Kali formulated products under fasting conditions

Drug: Clonazepam

B

ACTIVE COMPARATOR

Subjects received the Roche's product under fasting conditions

Drug: Klonopin Wafers

Interventions

Clonazepam DRUG

ODT, 1 mg

Also known as: Klonopin Wafers

A

Klonopin Wafers DRUG

ODT, 1 mg

Also known as: Clonazepam ODT

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Cetero Research, San Antonio: collaborator

MeSH Terms

Conditions

Fasting

Interventions

Clonazepam

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ali Ziaee

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

• Gary Shillito

  Cetero Research, San Antonio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: March 1, 2004
• Primary Completion: April 1, 2004
• Study Completion: May 1, 2004
• Last Updated: April 4, 2008

Record last verified: 2008-04