A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 25 mg Carbidopa, 100 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 25 mg Carbidopa and 100 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fasting Conditions

Novartis1 site in 1 country42 target enrollmentJune 2006

ConditionsHealthy

DrugsELC200 (carbidopa+levodopa+entacapone)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Novartis
Enrollment: 42
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis

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)

Outcomes

Primary Outcomes

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