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

NCT ID: NCT00415844

Last Updated: 2007-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30

Brief Summary

The purpose of this study is to 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ELC200 (carbidopa+levodopa+entacapone)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative Site

Nuremberg, , Germany

Countries

Germany

Other Identifiers

CELC200A2103

Identifier Type: -

Identifier Source: org_study_id