- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146028
Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting Conditions
Randomized, 2-way Crossover, Bioequivalence Study of Tizanidine Hydrochloride 4mg Tablets and Zanaflex® 4mg Tablets Administered As 1 x 4mg Tablet in Healthy Adult Subjects Under Fasting Conditions
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Sainte-Foy (Quebec), Canada
- Anapharm Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site). Subjects must meet all of the following criteria in order to be included in the study:
- Subjects will be females and/or males, smokers or non-smokers, 18 years of age and older.
- Female subjects will be post-menopausal or surgically sterilized.
- Post-menopausal status is defined as absence of menses for the past 12 months.
- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
Exclusion Criteria:
Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant abnormalities found during medical screening.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Clinically significant illnesses within 4 weeks of the administration of study medication.
- History of neuromuscular disease.
- Abnormal laboratory tests judged clinically significant.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, or diastolic blood pressure lower than 70 or over 90; or heart rate less than 60 bpm) at screening.
- Subjects with BMI ≥ 30.0.
- History of allergic reactions to tizanidine hydrochloride.
- Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub investigator, contraindicates the subject's participation in this study.
- Positive urine drug screen at screening.
- Positive testing for hepatitis B, hepatitis C or HN at screening.
- Positive urine pregnancy test at screening.
- Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (l Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot)within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- Subjects who have taken prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Smoking more than 25 cigarettes per day.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Any reason which, in the opinion of the medical sub investigator, would prevent the subject from participating in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tizanidine HCl 4 mg
Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited
|
Tizanidine HCl Tablets 4 mg
Other Names:
|
Active Comparator: Zanaflex
Zanaflex 4 mg Tablets
|
Tizanidine HCl Tablets 4 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on Cmax and AUC parameters
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benoit Girard, M.D, Anapharm
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anticonvulsants
- Neuromuscular Agents
- Muscle Relaxants, Central
- Tizanidine
Other Study ID Numbers
- 01220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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