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ELC200

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials4
Total Enrollment168

FDA Designations

No designations recorded

Clinical trial landscape

ELC200 · 4 trials · 1 indication

Phase 1 4
NCT00415922Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy VolunteersHealthy
COMPLETED42 Analytics
NCT00415831Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy VolunteersHealthy
COMPLETED42 Analytics
NCT00415844Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy VolunteersHealthy
COMPLETED42 Analytics
NCT00415740Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy VolunteersHealthy
COMPLETED42 Analytics
PHASE1COMPLETED
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about ELC200

What is ELC200 used for?

ELC200 is a small molecule being developed by Novartis AG for use in healthy volunteers. It is currently in Phase 1 clinical development, with all four completed trials conducted in healthy participants to assess bioequivalence of carbidopa/levodopa/entacapone combinations.

Who makes ELC200?

ELC200 is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 1 clinical development.

What phase is ELC200 in?

ELC200 is in Phase 1 clinical development. All four clinical trials associated with the drug have been completed, with a total enrollment of 168 healthy volunteers across studies conducted in Germany.

What clinical trials is ELC200 in?

ELC200 has been studied in four completed Phase 1 bioequivalence trials: NCT00415740, NCT00415831, NCT00415844, and NCT00415922. Each trial enrolled 42 healthy volunteers in Germany and compared carbidopa/levodopa/entacapone combination formulations.

Is ELC200 the same as carbidopa/levodopa/entacapone?

ELC200 is being studied as a combination product containing carbidopa, levodopa, and entacapone. The clinical trials evaluate the bioequivalence of this combination versus separate administration of carbidopa/levodopa plus entacapone in healthy volunteers.