An Open-Label, Fasting, Crossover, Single-Dose Pharmacokinetic Study of Four Formulations of Racecadotril
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration
研究概览
简要总结
This study is designed to compare the pharmacokinetics of four products used for treatment of acute diarrhea.
详细描述
The study will be a single dose, randomized, four -way, four-sequence crossover study in 24 healthy subjects, with equal numbers of males and females (minimum of 10 of either gender). Subjects who drop out will not be replaced. The four doses of medication given in the study (a single dose in each of the four study periods) will be separated by a washout period of at least 7 calendar days. In each study period, 17 blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of thiorphan (the active metabolite) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
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
- •Male or female subjects (equal numbers of males and females)
- •Volunteers aged of at least 18 years but not older than 55 years
- •Subjects will have a Body Mass Index (BMI) within protocol-specified parameters.
- •Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
- •Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
- •Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Seated pulse rate and blood pressure within protocol-specified parameters.
- •Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the families of each)
- •Females who are pregnant or are lactating
- •Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
- •History of significant hypersensitivity to racecadotril or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •Use of certain drugs/medications within protocol-specified timeframes
- •Medical history or condition that may, per protocol or in the opinion of the investigator, adversely affect the safety of the study subject or compromise study results.
研究组 & 干预措施
FCT
A single 2 x100 mg dose of an experimental Racecadotril Film-coated tablet (FCT) administered orally with 240 ml of water, with a 7- day washout between visits.
干预措施: Racecadotril (Drug)
RPB
A single 2 x100 mg dose of an experimental Racecadotril Powder Blend administered orally with 240 ml of water, with a 7- day washout between visits.
干预措施: Racecadotril (Drug)
TFT
A single 2 x 100 mg dose of a marketed Tiorfast® capsule administered orally with 240 ml of water, with a 7-day washout between visits.
干预措施: Racecadotril (Drug)
TFR
A single 175 mg dose of a marketed Tiorfanor® 175 mg FCT administered orally with 240 ml of water, with a 7-day washout between visits.
干预措施: Racecadotril (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration
时间窗: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
AUC(0-t)
时间窗: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
AUC(0-t) is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour\*nanograms (ng) per milliliter (mL).
AUC(0-∞)
时间窗: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
AUC (0-∞) is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.
次要结局
- Time of Maximum Concentration(During 12 hours post-dose)
- Terminal Elimination Rate Constant(During 12 hours post-dose)
- Terminal Phase Plasma Half-Life(During 12 hours post-dose)
- Lag Time(During 12 hours post-dose)