Comparative Pharmacokinetics for Bioequivalence of Pramipexole Dihydrochloride Extended-Release Tablets in Fasting and Fed Chinese Healthy Volunteers: A Randomized, Open-label, Single-dose, Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd. with the reference formulation (MIRAPEX ER®，Boehringer Ingelheim GmbH of Germany) to evaluate the bioequivalence of single dose in Chinese healthy subjects under fasting and fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 18 years or older (inclusive);
- •Body weight ≥ 50 kg for males and ≥ 45 kg for females, with body mass index (BMI) between 19 and 26 (inclusive);
- •No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), or abdominal ultrasound at screening；
- •All subjects must be willing to use appropriate contraceptive measures from the screening period, throughout the trial drug administration period, and until one month after drug discontinuation;
- •Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
排除标准
- •Subjects with serious systemic diseases, infectious diseases, or mental disorders that, in the investigator's opinion, make them unsuitable for participation in this study;
- •History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents, and siblings);
- •Known or suspected history of allergy to the investigational drug or drugs with a similar chemical structure;
- •Presence of conditions that may affect drug absorption, distribution, metabolism, or excretion, including but not limited to any of the following:
- •History of inflammatory bowel disease, gastritis, gastrointestinal ulcer, gastrointestinal bleeding, or other clinically significant gastrointestinal abnormalities.
- •History of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, enterectomy, gastric bypass, gastric partitioning, or gastric banding).
- •History of clinically significant renal disease or impaired renal function, or laboratory abnormalities at screening.
- •Liver disease or laboratory abnormalities indicative of clinically significant hepatic impairment at screening.
- •Subjects with positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis antibody;
- •History of drug abuse or alcohol abuse within 12 months prior to screening (consuming more than 2 units of alcohol per day or more than 14 units per week; 1 unit = 355 mL beer, 30 mL liquor, or 150 mL wine);
- •Average daily smoking of more than 5 cigarettes within 3 months prior to screening (assessed by interview at screening), or inability to refrain from smoking during the entire study period;
- •Blood donation or blood loss of ≥ 400 mL within 3 months prior to screening;
- •Participation in another clinical trial within 3 months prior to screening;
- •Use of any prescription medication within 4 weeks prior to screening;
- •Use of over-the-counter drugs, health supplements, herbal medicines, or traditional Chinese medicines within 2 weeks prior to screening. Refusal to discontinue any beverages or foods containing xanthines, such as caffeine (coffee, tea, cola, chocolate, etc.), from 48 hours before dosing until the end of the study;
- •Pregnant or breastfeeding women;
- •History of orthostatic hypotension, sudden vertigo, or transient syncope;
- •Subjects deemed unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Test formulation
pramipexole dihydrochloride extended-release tablets (0.375 mg/table)，Manufacturer: Haisco Pharmaceutical Group Co., Ltd
干预措施: Test formulation（pramipexole dihydrochloride extended-release tablets） (Drug)
Reference formulation
pramipexole dihydrochloride extended-release tablets (MIRAPEX ER®，0.375 mg/table) Manufacturer: Boehringer Ingelheim GmbH of Germany
干预措施: Reference formulation（MIRAPEX ER®） (Drug)
结局指标
主要结局
Cmax
时间窗: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
AUC(0-t)
时间窗: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
AUC(0-∞)
时间窗: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
Cmax (Maximum Concentration)
时间窗: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t)
时间窗: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)
时间窗: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
次要结局
- AEs(From the time of signing ICF to the end of follow-up，up to 10 days)
- AEs (Adverse Events)(From the time of signing ICF (Informed Consent Form) to the end of follow-up，up to 10 days)