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

NCT01146028 | Completed Phase 1

• 1 other identifier: 01220
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  3 months

Study Arms (2)

Tizanidine HCl 4 mg

EXPERIMENTAL

Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited

Drug: Tizanidine

Zanaflex

ACTIVE COMPARATOR

Zanaflex 4 mg Tablets

Drug: Tizanidine

Interventions

Tizanidine DRUG

Tizanidine HCl Tablets 4 mg

Also known as: Zanaflex 4 mg

Tizanidine HCl 4 mg; Zanaflex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy (Quebec), Canada

Location

MeSH Terms

Interventions

tizanidine

Study Officials

• Benoit Girard, M.D

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: June 17, 2010
• Study Start: September 1, 2001
• Primary Completion: September 1, 2001
• Study Completion: November 1, 2001
• Last Updated: January 13, 2012

Record last verified: 2010-06

Locations

CA (1)