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ELC200

Phase 1

Undisclosed | Small molecule | Other |Novartis AG|Trials 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

ELC200 clinical trials

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?

ELC200 is an investigational small molecule developed by Novartis AG. It is a fixed-dose combination of carbidopa, levodopa, and entacapone. The program has been studied in Phase 1 bioequivalence trials in healthy volunteers in Germany, with four completed studies and 168 total participants enrolled.

Who makes ELC200?

ELC200 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 bioequivalence studies of the carbidopa, levodopa, and entacapone combination conducted in Germany.

What phase is ELC200 in?

ELC200 is in Phase 1 development. Four Phase 1 bioequivalence trials have been completed, and no trials are currently active. The studies enrolled 168 participants in total and were conducted in healthy volunteers in Germany.

What clinical trials is ELC200 in?

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

What is ELC200 used for?

ELC200 is an investigational fixed-dose combination of carbidopa, levodopa, and entacapone. Its clinical program consists of Phase 1 bioequivalence studies in healthy volunteers rather than patient populations, so the trials evaluated drug exposure comparisons rather than treatment outcomes in a specific disease.