Levodopa Concentration Profile With Stalevo 75/125 mg
NEWSTA
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedAugust 13, 2010
August 1, 2010
2 months
November 23, 2009
August 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2-11 weeks
Secondary Outcomes (1)
Cmin, AUCo-tau
each subject 3 PK days between 1-6 days
Study Arms (2)
Stalevo (levodopa/carbidopa/entacapone)
EXPERIMENTAL125mg 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.
Sinemet (levodopa/carbidopa)
ACTIVE COMPARATOR150mg or 100mg of levodopa during treatment period 3 in study groups 1 and 2 respectively
Interventions
150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval
150 or 100 mg levodopa q.i.d. in 3.5 hr interval
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Phase I Unit, Orion Pharma
Espoo, 02101, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimmo Ingman
Orion Corporation, Orion Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 23, 2009
First Posted
February 18, 2010
Study Start
December 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
August 13, 2010
Record last verified: 2010-08