To Determine Bioequivalence Under Fasting ConditionsPhase 1NCT00652639
Bioavailability Study of Clonazepam Tablets Under Fasting Conditions
A Phase 1 study testing Clonazepam and Klonopin in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc..
Trial summary
To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fasting Conditions
- What is being tested?
- Clonazepam and Klonopin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Apr 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
About this study
Official title: 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
Read the 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.
- Being tested
- Clonazepam, Klonopin
- Keywords
- bioequivalence, Clonazepam tablets, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonazepamDrug
Also called Klonopin
Tablets, 1 mg, single-dose
KlonopinDrug
Also called Clonazepam tablets
tablets, 1 mg, single-dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received the kali formulated products under fasting conditions Receives: Drug: Clonazepam |
| B | Active comparator | Subjects received the Roche formulated products under fasting conditions Receives: Drug: Klonopin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startFeb 2004
- Primary completionMar 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fasting ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Investigators
- Irwin Plisco, Principal investigator, Cetero Research, San AntonioGary Shillito, Study director, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652639
- Sponsor's protocol ID
- B043201
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00652639
- Acronym / sponsor ID
- B043201
- Keywords
- bioequivalence, Clonazepam tablets, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Study start
- Feb 2004
- Primary completion
- Mar 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ClonazepamSubjects received the kali formulated products under fasting conditions |
| B | Active comparator | Drug: KlonopinSubjects received the Roche formulated products under fasting conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClonazepamAlso: KlonopinTablets, 1 mg, single-dose | Drug | A |
| KlonopinAlso: Clonazepam tabletstablets, 1 mg, single-dose | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irwin Plisco principal investigator
Cetero Research, San Antonio
Gary Shillito study director
Cetero Research, San Antonio
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clonazepam and Klonopin in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Extend of Absorption (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2008.