Levodopa Concentration Profile With Stalevo 75/125 mg (NEWSTA)

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01070628
First received: November 23, 2009
Last updated: August 12, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after each dose throughout the day compared to Cmax after the first dose.


Condition Intervention Phase
Parkinson's Disease
Drug: Stalevo (levodopa/ carbidopa/ entacapone)
Drug: Sinemet (levodopa/carbidopa)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day. [ Time Frame: 2-11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmin, AUCo-tau [ Time Frame: each subject 3 PK days between 1-6 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stalevo (levodopa/carbidopa/entacapone)

125mg or 75mg of levodopa during treatment period 1 in groups 1 and 2 respectively.

150mg or 100mg of levodopa during treatment period 2 in groups 1 and 2 respectively.

Drug: Stalevo (levodopa/ carbidopa/ entacapone)
150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval
Other Name: Stalevo
Active Comparator: Sinemet (levodopa/carbidopa)
150mg or 100mg of levodopa during treatment period 3 in study groups 1 and 2 respectively
Drug: Sinemet (levodopa/carbidopa)
150 or 100 mg levodopa q.i.d. in 3.5 hr interval
Other Name: Sinemet

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent (IC) obtained.
  • Good general health ascertained by detailed medical history, and laboratory and physical examinations.
  • Finnish speaking males or females, 18-70 years of age inclusive.
  • Normal weight defined as body mass index (BMI) 18.5-30.0 kg/m2 (inclusive) (BMI = weight/height2).
  • Weight at least 50.0 kg.
  • Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).

Exclusion Criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, contraceptives or hormone replacement therapy are allowed.
  • Intake of any medication that could affect the outcome of the study.
  • Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG]) and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
  • Orthostatic hypotension; systolic and diastolic BP and heart rate HR after 3 minutes in supine position and after 3 minutes of standing:
  • decrease of ≥ 20 mmHg for systolic BP
  • decrease of ≥ 10 mmHg for diastolic BP.
  • Strong tendency to motion sickness.
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
  • Pregnant or lactating females.
  • Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilization, spermicidal foam/Vagitorie, condom on male partner). Double methods (mentioned above) of contraception is needed during the study. (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
  • Recent or current (suspected) drug abuse or positive result in the drug abuse test.
  • Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent]).
  • Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the stay at the study centre.
  • Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages while at the study centre.
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
  • Administration of another investigational treatment within 90 days prior to the first study treatment administration.
  • Unsuitable veins for repeated venipuncture or for cannulation.
  • Predictable poor compliance or inability to communicate well with the study centre personnel.
  • Inability to participate in all treatment periods.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070628

Locations
Finland
Phase I Unit, Orion Pharma
Espoo, Finland, 02101
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Kimmo Ingman Orion Corporation, Orion Pharma
  More Information

No publications provided

Responsible Party: Irja Korpela, Clinical Study Manager, Orion Pharma
ClinicalTrials.gov Identifier: NCT01070628     History of Changes
Other Study ID Numbers: 2939131
Study First Received: November 23, 2009
Last Updated: August 12, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Orion Corporation, Orion Pharma:
Pharmacokinetic

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
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
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on August 28, 2014