Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00415831

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: ELC200 (carbidopa+levodopa+entacapone)	Phase I

Drug Information available for: Entacapone Levodopa Carbidopa OR 611

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Outcome Measures:

Safety and tolerability

Estimated Enrollment:	42
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415831

Locations

Germany
Novartis Investigative Site
Nuernberg, Germany

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Investigator site

More Information

Study ID Numbers:	CELC200A2102
Study First Received:	December 22, 2006
Last Updated:	June 21, 2007
ClinicalTrials.gov Identifier:	NCT00415831
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Bioequivalence
bioavailability
carbidopa
levodopa

entacapone
fed condition
Healthy volunteers study

Study placed in the following topic categories:

Levodopa
Dopamine
Malnutrition
Sinemet

Carbidopa
Healthy
Entacapone

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiparkinson Agents

Enzyme Inhibitors
Dopamine Agonists
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009