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ELC200

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Jun 22, 2007

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
RandomizedUNCONTROLLEDBiomarker
Total Trials4
Total Enrollment168
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00415922Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy VolunteersPHASE1 COMPLETED 42 — — Jul 1, 2006 -Jun 22, 20071 Germany
NCT00415831Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy VolunteersPHASE1 COMPLETED 42 — — Jun 1, 2006 -Jun 22, 20071 Germany
NCT00415844Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy VolunteersPHASE1 COMPLETED 42 — — Jun 1, 2006 -Jun 22, 20071 Germany
NCT00415740Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy VolunteersPHASE1 COMPLETED 42 — — May 1, 2006 -Jun 22, 20071 Germany
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Study Endpoints
Primary Endpoints
Bioequivalence between 37.5 mg carbidopa/150 mg levodopa/200 mg entacapone single dose combination and 37.5 mg carbidopa/150 mg levodopa single dose combination plus 200 mg entacapone single dose when administered under fasting conditions
Bioequivalence between 12.5mg carbidopa/50 mg levodopa/200 mg entacapone single dose combination 12.5 mg carbidopa/50 mg levodopa single dose combination plus 200 mg entacapone single dose when administered as single doses under fed conditions
Bioequivalence between 25 mg carbidopa/100 mg levodopa/200 mg entacapone single dose combination and 25 mg carbidopa/100 mg levodopa single dose combination plus 200 mg entacapone single doses when administered under fasting conditions
Bioequivalence between 12.5mg carbidopa/50 mg levodopa/100 mg entacapone single dose combination and 12.5 mg carbidopa/50 mg levodopa single dose combination plus 200 mg entacapone single dose when administered under fasted conditions
Secondary Endpoints
Safety and tolerability
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
ELC200 (carbidopa+levodopa+entacapone)DRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects age 18 to 55 years of age included, and in good health * At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when ...

Countries:Germany
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