Recent Updates
Recently added Catalysts

Ritalin-

Phase 1

Pharmacokinetics | Small molecule | Other |Johnson & Johnson|Last Updated: Dec 11, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01118702A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy VolunteersPHASE1 COMPLETED 30 — — May 1, 2010Jun 1, 2010Dec 11, 2012 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The primary objective of this exploratory study is to characterize the plasma concentrations of of methylphenidate from Concerta®, Ritalin-SR® and Novo-Methylphenidate ER-C ® tablets in healthy adult volunteers under fasting conditions.
Plasma samples will be taken via in-dwelling catheter predose, and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 11, 12, 14, 16, 20 and 24 hours post dose.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
001ACTIVE_COMPARATORConcerta one 54mg tablet once
002ACTIVE_COMPARATORRitalin-SR 3-20mg tablets once
003ACTIVE_COMPARATORNovo-Methylphenidate ER-C one 54mg tablet once
Interventions
NameTypeDescription
Ritalin-SRDRUG3-20mg tablets, once
ConcertaDRUGone 54mg tablet, once
Novo-Methylphenidate ER-CDRUGone 54mg tablet, once
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * The volunteer will be assessed against all protocol specified criteria at investigator site: If a female, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent or, if sexually active, be practicing an effective method of birth contr...

Unlock Eligibility Criteria