Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Cmax - Maximum Observed Plasma Concentration
研究概览
简要总结
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.
详细描述
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A signed and dated informed consent form (ICF) before any study-specific screening procedure was performed,
- •Male or female subjects aged 18 to 45 years, inclusive,
- •Body mass index (BMI) between 19 and 30 kg/m2,
- •Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG),
- •Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,
- •Clinical laboratory test results clinically acceptable at screening and on D-1 of each treatment period,
- •Negative screen for alcohol and drugs of abuse at screening and on D-1 of each treatment period,
- •Non-smokers or ex-smokers for at least 3 months,
- •Volunteer able to participate, and willing to give written informed consent and comply with the study restrictions,
- •Was not of childbearing potential by reason of surgery or, if of childbearing potential, uses an effective non-hormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for the entire duration of the study,
- •Negative serum pregnancy test at screening and a negative urine pregnancy test on D-1 of each treatment period.
排除标准
- •Any clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or had a clinically relevant surgical history,
- •Any clinically relevant abnormality in the coagulation tests,
- •Any clinically relevant abnormality in the liver function tests,
- •History of relevant atopy or drug hypersensitivity,
- •History of alcoholism and/or drug abuse,
- •Current 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°)],
- •Any significant infection or known inflammatory process on screening or admission to each treatment period,
- •Any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period,
- •Use of medicines within 2 weeks of admission to first period that could affect the subject's safety or other study assessments, in the investigator's opinion,
- •Previously received opicapone,
- •Involvement in other clinical trials of any type within 90 days prior to screening,
- •Participation in more than 2 clinical trials within the 12 months prior to screening,
- •Blood donation or received any blood transfusion or any blood products within the 3 months prior to screening,
- •Vegetarian, vegan or had medical dietary restrictions,
- •Subject not able to communicate reliably with the investigator,
- •Subjects who were unlikely to co-operate with the requirements of the study,
- •Subjects who were unwilling or unable to give written informed consent,
- •Pregnant or breast-feeding,
- •If of childbearing potential, a positive serum pregnancy test,
- •Volunteer who did not use an accepted effective contraceptive method or used oral contraceptives,
研究组 & 干预措施
BIA 9-1067 non-micronized - micronized
Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized
干预措施: BIA 9-1067 non-micronized (Drug)
BIA 9-1067 non-micronized - micronized
Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized
干预措施: BIA 9-1067 micronized (Drug)
BIA 9-1067 micronized - non-micronized
Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
干预措施: BIA 9-1067 non-micronized (Drug)
BIA 9-1067 micronized - non-micronized
Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
干预措施: BIA 9-1067 micronized (Drug)
结局指标
主要结局
Cmax - Maximum Observed Plasma Concentration
时间窗: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Maximum observed plasma concentration of BIA 9-1067
次要结局
- AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration(before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.)
- Tmax - Time of Occurrence of Cmax of BIA 9-1067(before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.)
- AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity(before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.)