Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ELC200 (carbidopa+levodopa+entacapone)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00415922

CELC200A2104

Details and patient eligibility

About

The purpose of this study is assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 required after three (3) minutes in the standing position. Vital signs should be within the normal ranges
Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
Female subjects must have undergone hysterectomy, or must be postmenopausal.

Exclusion criteria

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
Significant illness within two weeks prior to dosing
Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
Women of child bearing potential ( WOCBP)
History or presence of glaucoma or any suspicious undiagnosed skin lesions