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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00415922
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-12-22
• Study First Submitted QC: 2006-12-23
• Study First Posted: 2006-12-25
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-21
• Last Update Posted: 2007-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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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

Other protocol-defined inclusion/exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Nuernberg, Germany