NCT04513340Unknown1 期
AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- AUC0-∞
研究概览
简要总结
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics
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
- •Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).
- •Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg / height in m
- •Not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
- •Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- •Able to give voluntary written informed consent for participation in the trial.
- •In case of female subjects:
- •a. Surgically sterilized at least 6 months prior to study participation or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- •And b. Serum Pregnancy test must be negative.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug.
- •History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •Ingestion of a medicine (prescribed & over the counter (OTC) medication including herbal remedies) at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- •Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period I.
- •Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study.
- •The presence of clinically significant abnormal laboratory values during screening.
- •History or presence of psychiatric disorders.
- •A history of difficulty in donating blood.
- •Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**.
- •** If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- •A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •A positive test result for HIV (1 &/or 2) antibody.
- •An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- •Consumption of grapefruit or grapefruit products within 72 hours prior to dosing in period-I.
- •Difficulty in swallowing oral solid dosage form like tablets or capsules.
- •Nursing mothers (females).
研究组 & 干预措施
Treatment A
Experimental
Treatment A will be given under fed conditions by intra-oral single dose administration
干预措施: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS (Drug)
Treatment B
Experimental
Treatment B will be given intra-orally and orally under fed conditions by single dose administration
干预措施: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS (Drug)
Treatment C
Experimental
Treatment C will be given orally under fed conditions by single dose administration
干预措施: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS (Drug)
Treatment D
Experimental
Treatment D will be given orally under fasting conditions by single dose administration
干预措施: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS (Drug)
结局指标
主要结局
AUC0-∞
时间窗: Day 1 and Day 2
Pharmacokinetics Measurements to Determine AUC0-∞ for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
Cmax
时间窗: Day 1 and Day 2
Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
AUC0-t
时间窗: Day 1 and Day 2
Pharmacokinetics Measurements to Determine AUC0-t for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
次要结局
- Tmax(Day 1 and Day 2)
- t1/2(Day 1 and Day 2)
研究者
研究点 (1)
Loading locations...
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