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Tizanidine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 13, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01065987Bioequivalence Study of Tizanidine HCl 4mg Tablets of Dr.Reddy's Under Fed ConditionsPHASE1 COMPLETED 24Sep 1, 2001Nov 1, 2001Feb 10, 20101 Canada
NCT01146028Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting ConditionsPHASE1 COMPLETED 42Sep 1, 2001Nov 1, 2001Jan 13, 20121 Canada
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Study Endpoints
Primary Endpoints
Bioequivalence study of Tizanidine HCl Tablets 4 mg of Dr.Reddy's Laboratories Limited under Fed Conditions
3 months
Bioequivalence based on Cmax and AUC parameters
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Tizanidine HCl 4 mgEXPERIMENTALTizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited
ZanaflexACTIVE_COMPARATORZanaflex 4 mg Tablets
Interventions
NameTypeDescription
TizanidineDRUGTizanidine HCl Tablets 4 mg
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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: *...

Countries:Canada
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