Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone

This is an interventional treatment trial for Parkinson Disease Read More

Inclusion Criteria:

• Subjects signed and dated the ICF before any study-specific screening procedure.
• Male and female subjects, between 18 and 55 years of age (inclusive).
• BMI between 18 and 30 kg/m² inclusive.
• Subjects have a supine blood pressure (after at least 5 minutes rest in supine position) of: systolic blood pressure ≥90 and <140 mmHg, diastolic blood pressure ≥50 and <90 mmHg and a pulse rate ≥50 and ≤90 bpm (beats per minute).
• Subjects have no clinically relevant abnormal ECG parameters: heart rate ≥50 and ≤90 bpm, PR interval ≤ 220 milliseconds (ms), QRS duration ≤120 ms, QTcB interval ≤450 ms. No clinically relevant pathological findings in the 12-lead ECG.
• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
• Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibodies (HCVab) and anti-HIV antibodies (HIV-1 and HIV-2 Ab) at screening.
• Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
• Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
• Non-smokers or ex-smokers for at least 3 months.
• If female, the pregnancy test at screening and at admission to each treatment period must be negative.
• Female subjects are of non-childbearing potential (postmenopausal [no menses for at least 1 year] or surgically sterile [tubal ligation, hysterectomy or bilateral oophorectomy]). Female subjects of childbearing potential must use an acceptable method of non-hormonal method of contraception and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical investigation. Acceptable methods for this study are: intrauterine device, condom or occlusive cap (diaphragm or cervical or vault caps) with spermicide, true abstinence or vasectomized male partner, provided that he is the sole partner of that subject).
• Able to participate, and willing to give written ICF and comply with the study restrictions.

Exclusion Criteria:

• Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or have a clinically relevant surgical history.
• Subjects with clinically relevant neurologic or psychiatric illness.
• Subjects with a history of symptomatic orthostatic hypotension.
• Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) as judged by the Principal investigator.
• Subjects with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption
• Subjects with clinically significant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the kidney function tests especially creatinine above 1.2 x upper limit of normal (ULN) and/or liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST],) above 1.25 x ULN confirmed by two repeated measurements, when it is checked during the screening laboratory tests.
• Subjects with a history of relevant atopy or drug hypersensitivity.
• Subjects with a history of alcoholism and/or drug abuse.
• Consumption of more than 14 units of alcohol per week [1 unit of alcohol = 280 ml beer (3-4°) = 100 ml wine (10-12°) = 30 ml spirits (40°)].
• Subjects with a significant infection or known inflammatory process at screening or admission to each treatment period.
• Subjects with acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission to each treatment period.
• Use of medicines within 2 weeks prior to the planned first drug administration that may affect the safety or other study assessments, in the investigator's opinion (excluding single use of up to 1000 mg paracetamol).
• Use of any investigational drug or participation in any clinical trial within 30 days or 10 half-life, whatever is longer, prior to the planned first drug administration.
• Donation or receipt of any blood or blood products within the 2 months prior to the planned first drug administration.
• Subjects who are vegetarians, vegans or have medical dietary restrictions.
• Subjects who cannot communicate reliably with the investigator.
• Subjects who are unlikely to co-operate with the requirements of the study.
• Subjects who are unwilling or unable to give written informed consent.
• If female: She is pregnant or breast-feeding.