Open-label, Two-treatment, 4-period Replicated Crossover Study in Healthy Subjects to Investigate the Plasma Pharmacokinetics of Levodopa and Carbidopa After Oral Administration of Single Doses of Two Fixed-dose Combination Products
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax and AUC(0-tz) of levodopa and carbidopa
研究概览
简要总结
The study is carried-out to describe and compare the plasma pharmacokinetics of levodopa and carbidopa after oral single-dose administration of 100 mg levodopa plus 25 mg carbidopa by means two fixed combination products (test: Isicom® 100/25 mg; reference: Nacom® 100/25 mg).
Additionally, to describe and compare the safety and tolerability of the two investigational treatments administered to healthy subjects.
详细描述
Isicom® 100/25 mg and Sinemet® (Trade name in Germany: Nacom®) 100/25 mg are authorised fixed-combination products containing 100 mg levodopa plus 25 mg carbidopa. These two formulations were tested for bioequivalence in 1997 (DESITIN trial № LCD-010/K); based on the regulatory provisions in place at that time (CPMP/EWP/QWP/1401/98), the two formulations could be accepted to be bioequivalent.
The present study is proposed to be conducted in order to verify and confirm the bioequivalence of Isicom® 100/25 mg (test formulation) and Nacom® 100/25 mg (reference formulation) in agreement with the pertinent regulatory guidance that came in place 2010 (CHMP Guideline On The Investigation Of Bioequivalence - CPMP/EWP/QWP/1401/98- Rev. 1/ Corr - Jan.2010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
- •Race: Caucasian
- •Age: 18 to 45 years
- •Body weight: 50 100 kg
- •Body Mass Index: 18 26 kg.m-2
- •Healthy based on the screening examination
- •Willing and able to provide informed consent
排除标准
- •Previous participation in this trial or participant in any other trial during the last 90 days
- •Donation of blood or plasma during the last 90 days or a history of blood loss exceeding 300 mL within the last 3 months
- •History of any clinically relevant allergy including hypersensitivity to levodopa or carbi-dopa and related excipients
- •Presence of any acute or chronic infection
- •Presence or history of any relevant co-morbidity
- •Resting systolic blood pressure > 160 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
- •Clinically relevant ECG-abnormalities, in particular prolonged QTc(F) of > 450 msec in males and > 460 msec in females
- •Presence of any relevant abnormality in the laboratory safety tests, especially low haemo-globin (< 120 g/L in females and (< 136 g/L in males) and increased liver enzymes (2 times the upper limit of the normal range)
- •Positive serology for HBsAg or anti HCV
- •Positive HIV test
- •Positive alcohol or urine drug test at screening
- •Regular use of any prescription medicine (except for contraceptives) or over-the-counter product, herbal product, hormone supplement, etc. in the 30 days prior to the Screening visit
- •History of alcohol and/or drug abuse and/or daily use of > 30 g alcohol
- •Smoking more than 10 cigarettes/day or equivalent of other tobacco products
- •Suspicion or evidence that the subject is not trustworthy and reliable
- •Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard.
- •Positive pregnancy test
- •Lactating
- •Female subjects of child-bearing potential not using appropriate contraception in the 3 weeks prior to enrolment until two weeks after the last dose of the trial medication
研究组 & 干预措施
Levodopa Carbidopa 100/25 tablets Test 1
single oral dose of levodopa carbidopa immediate release tablets
干预措施: Levodopa Carbidopa immediate release tablets (Drug)
Levodopa Carbidopa 100/25 tablets Ref. 1
single oral dose of levodopa carbidopa immediate release tablets
干预措施: Levodopa Carbidopa immediate release tablets (Drug)
Levodopa Carbidopa 100/25 tablets Test 2
single oral dose of levodopa carbidopa immediate release tablets
干预措施: Levodopa Carbidopa immediate release tablets (Drug)
Levodopa Carbidopa 100/25 tablets Ref. 2
single oral dose of levodopa carbidopa immediate release tablets
干预措施: Levodopa Carbidopa immediate release tablets (Drug)
结局指标
主要结局
Cmax and AUC(0-tz) of levodopa and carbidopa
时间窗: 12 hours
Cmax (maximal plasma concentration), AUC (area under the curve)
次要结局
未报告次要终点