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About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
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:
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 illnesses within 4 weeks of the administration of study medication.
Primary purpose
Allocation
Interventional model
Masking
42 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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