A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the Two Different Products Containing 10 mg Film Coated Tablet After Oral Administration to 38 Healthy Adult Volunteers Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.
详细描述
A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteers under fasting conditions. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Plasma concentrations of Rosuvastatin were analyzed and determined using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent is obtained for study.
- •Age 18 - 55 years,
- •Body mass index between 18.5 and 30 kg/m2
- •Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
- •Vital signs without significant deviations.
- •All laboratory screening results are within the normal range or clinically non-significant
排除标准
- •History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
- •History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
- •Any confirmed significant allergic reactions against any drug, or multiple allergies.
- •Clinically significant illness 28 days before study phase I.
- •Alcohol or any solvent intake.
- •Regular use of medication.
- •Positive urine screening of drugs of abuse.
- •Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
- •History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
- •Blood donation within the past 60 days.
- •Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
研究组 & 干预措施
Rosuvastatin 10 mg film coated tablets
Single oral dose of 1 tablet (10 mg)
干预措施: Rosuvastatin 10 mg (Drug)
Crestor® 10 mg film coated tablets
Single oral dose of 1 tablet (10 mg)
干预措施: Rosuvastatin 10 mg (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
Cmax is observed as the maximum of Rosuvastatin peak concentration
Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))
时间窗: Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
The AUC (0-t) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast).
Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))
时间窗: Pre-dose to infinite time
AUC(0-inf) "the area under the curve," which is a way of measuring the total amount of the active drug in a subject's system over a period of time from administration ("0") to the time that the drug is no longer present in the subject's body ("infinity")
次要结局
- Maximum time (Tmax)(Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours)
- Elimination Rate Constant (Kel)(Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours)
- Plasma concentration half-life (t1/2)(Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours)
研究者
Rania Mahmoud Mohamed
Unit director at FRC
Future University in Egypt