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Search / Trial NCT01070628

Levodopa Concentration Profile With Stalevo 75/125 mg

Launched by ORION CORPORATION, ORION PHARMA · Feb 17, 2010

Trial Information

Current as of June 25, 2025

Completed

Keywords

Pharmacokinetic

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Orion Corporation, Orion Pharma

Orion Corporation, a Finnish pharmaceutical and biotechnology company, is dedicated to developing innovative healthcare solutions that enhance the quality of life for patients worldwide. With a strong focus on research and development, Orion Pharma specializes in prescription medications, particularly in the fields of neurology, oncology, and critical care. The company is committed to advancing medical science through rigorous clinical trials and collaborations, aiming to bring forth effective therapies that address unmet medical needs while adhering to the highest ethical standards in clinical research.

Locations

Espoo, , Finland

Patients applied

0 patients applied

Trial Officials

Kimmo Ingman

Principal Investigator

Orion Corporation, Orion Pharma

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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