Bioequivalence Study of Tizanidine HCl 4mg Tablets of Dr.Reddy's Under Fed Conditions

Study Description

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Brief Summary:

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 fed conditions.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Tizanidine	Phase 1

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 fed conditions

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (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 Fed Conditions
Study Start Date :	September 2001
Actual Primary Completion Date :	September 2001
Actual Study Completion Date :	November 2001

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Tizanidine HCl 4 mg; Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited	Drug: Tizanidine; Tizanidine HCl Tablets 4 mg; Other Name: Zanaflex 4 mg
Active Comparator: Zanaflex; Zanaflex 4 mg Tablets	Drug: Tizanidine; Tizanidine HCl Tablets 4 mg; Other Name: Zanaflex 4 mg

Outcome Measures

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Primary Outcome Measures :

1. Bioequivalence study of Tizanidine HCl Tablets 4 mg of Dr.Reddy's Laboratories Limited under Fed Conditions [ Time Frame: 3 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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 Inc.

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.

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistant Manager, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:	NCT01065987 History of Changes
Other Study ID Numbers:	01221
First Posted:	February 10, 2010
Last Update Posted:	February 10, 2010
Last Verified:	February 2010

Additional relevant MeSH terms:

Tizanidine; Clonidine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; 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; Sympatholytics