Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Und...

http://clinicaltrials.gov/ct2/show/NCT01146028

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Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting Conditions

This study has been completed.
First Received on February 10, 2010. Last Updated on January 12, 2012 History of Changes Sponsor: Information provided by: ClinicalTrials.gov Identifier:

Dr. Reddy's Laboratories Limited Dr. Reddy's Laboratories Limited NCT01146028

Purpose
The purpose of this bioequivalence study is to compare the test Tizanidine Hydrochloride 4mg tablets of Dr.Reddys Laboratories Limited with reference zanaflex 4mg tablets of Elan in healthy adult subjects under fasting conditions. Condition Healthy Intervention Drug: Tizanidine Phase Phase I

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment Official Title: 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

Resource links provided by NLM: Drug Information available for: Tizanidine Tizanidine hydrochloride U.S. FDA Resources Further study details as provided by Dr. Reddy's Laboratories Limited: Primary Outcome Measures: Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ] Enrollment: Study Start Date: Study Completion Date: 42 September 2001 November 2001

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Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Und...

http://clinicaltrials.gov/ct2/show/NCT01146028

Primary Completion Date: September 2001 (Final data collection date for primary outcome measure) Arms Tizanidine HCl 4 mg: Experimental Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited Intervention: Drug: Tizanidine Zanaflex: Active Comparator Zanaflex 4 mg Tablets Intervention: Drug: Tizanidine Assigned Interventions Drug: Tizanidine Tizanidine HCl Tablets 4 mg Other Name: Zanaflex 4 mg Drug: Tizanidine Tizanidine HCl Tablets 4 mg Other Name: Zanaflex 4 mg

Detailed Description: 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

Eligibility
Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: Criteria 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. 18 Years and older Both Yes

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Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Und...

http://clinicaltrials.gov/ct2/show/NCT01146028

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146028

Locations Canada Anapharm Inc. Sainte-Foy (Quebec), Canada Sponsors and Collaborators Dr. Reddy's Laboratories Limited Investigators Principal Investigator: Benoit Girard, M.D Anapharm

More Information
No publications provided Responsible Party: ClinicalTrials.gov Identifier: Other Study ID Numbers: Study First Received: Last Updated: Health Authority: Assistant Manager, Dr. Reddy's Laboratories Limited NCT01146028 History of Changes 01220 February 10, 2010 January 12, 2012 United States: Food and Drug Administration

Additional relevant MeSH terms: Tizanidine Clonidine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Muscle Relaxants, Central Neuromuscular Agents

Parasympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Sympatholytics

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Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Und...

http://clinicaltrials.gov/ct2/show/NCT01146028

ClinicalTrials.gov processed this record on January 21, 2012

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