Clinical trial NCT00415831: Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
Official title: A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 12.5 mg Carbidopa, 50 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 12.5 mg Carbidopa and 50 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
bioavailability
carbidopa
levodopa
entacapone
fed condition
Healthy volunteers study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 fed conditions in healthy volunteers.


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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Safety and tolerability
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: