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

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ClinicalTrials.gov Identifier: NCT01146028
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : January 13, 2012
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE February 10, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date January 13, 2012
Study Start Date  ICMJE September 2001
Actual Primary Completion Date September 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting Conditions
Official Title  ICMJE 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
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 fasting conditions.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Tizanidine
Tizanidine HCl Tablets 4 mg
Other Name: Zanaflex 4 mg
Study Arms  ICMJE
  • Experimental: Tizanidine HCl 4 mg
    Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited
    Intervention: Drug: Tizanidine
  • Active Comparator: Zanaflex
    Zanaflex 4 mg Tablets
    Intervention: Drug: Tizanidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2010)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2001
Actual Primary Completion Date September 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01146028
Other Study ID Numbers  ICMJE 01220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistant Manager, Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benoit Girard, M.D Anapharm
PRS Account Dr. Reddy's Laboratories Limited
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP