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Nabumetone

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 19, 2010

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 Enrollment74
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01164813Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting ConditionsPHASE1 COMPLETED 44Mar 1, 2006Mar 1, 2006Jul 19, 20101 India
NCT01164826Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fed ConditionsPHASE1 COMPLETED 30Mar 1, 2006Mar 1, 2006Jul 19, 20101 India
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Study Endpoints
Primary Endpoints
Bioequivalence study is based on Cmax and AUC parameters
1 month
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NabumetoneEXPERIMENTALNabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
RelafenACTIVE_COMPARATORRelafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
Interventions
NameTypeDescription
NabumetoneDRUGNabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
RelafenDRUGRelafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: * Subjects who will provide written informed consent * Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. * Having a Body Mass I...

Countries:India
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