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Tetrabenazine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Oct 18, 2018

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_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03702855Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed ConditionsPHASE1 COMPLETED 48 — — Dec 1, 2015Dec 1, 2015Oct 11, 20181 India
NCT03696329Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting ConditionsPHASE1 COMPLETED 48 — — Oct 1, 2015Nov 1, 2015Oct 18, 20181 India
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Study Endpoints
Primary Endpoints
Area under curve
Pre-dose (within 1 hour prior to dosing), 0.33, 0.67, 1.00, 1.33, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 24.00 hours post dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Tetrabenazine TabletsEXPERIMENTALTetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited
XenazineACTIVE_COMPARATORXenazine Tablets 25 mg of Lundbeck Inc.
Interventions
NameTypeDescription
Tetrabenazine Tablets 25 mgDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and non pregnant female human subjects, age in the range of 18-45 years both inclusive. 2. Body mass index within the range of 18.5 kg/m2- 24.99 kg/m2 extremes included and body weight \> 50 kg. 3. Subjects with normal findings as determined by baseline history, physical...

Countries:India
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