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

NCT01065987 | Completed Phase 1

• 1 other identifier: 01221
• Study Type: interventional
• Target: 24
• 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 fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence study of Tizanidine HCl Tablets 4 mg of Dr.Reddy's Laboratories Limited under Fed Conditions

  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 - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 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.

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 8, 2010
• First Posted: February 10, 2010
• Study Start: September 1, 2001
• Primary Completion: September 1, 2001
• Study Completion: November 1, 2001
• Last Updated: February 10, 2010

Record last verified: 2010-02

Locations

CA (1)