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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00415740
First received: December 22, 2006
Last updated: June 21, 2007
Last verified: June 2007
History of Changes
  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 fasting conditions in healthy volunteers.


Condition Intervention Phase
Healthy
 Drug: ELC200 (carbidopa+levodopa+entacapone)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Bioequivalence between 12.5mg carbidopa/50 mg levodopa/100 mg entacapone single dose combination and 12.5 mg carbidopa/50 mg levodopa single dose combination plus 200 mg entacapone single dose when administered under fasted conditions

Secondary Outcome Measures:
  • Safety and tolerability

Estimated Enrollment: 42
Study Start Date: May 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: NCT00415740

Locations
Germany
Novartis Investigative Site
Nuernberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00415740     History of Changes
Other Study ID Numbers: CELC200A2101
Study First Received: December 22, 2006
Last Updated: June 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Bioequivalence
bioavailability
carbidopa
levodopa
 entacapone
fasting
Healthy volunteers study

Additional relevant MeSH terms:
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Entacapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013