A Randomized, Single-Dose, Partial Replicate, Three-period, Three-sequence, Open-Label, Bioequivalence Study Comparing Esomeprazole in Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))
研究概览
简要总结
The current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions.
详细描述
A randomized, single-dose, two-treatment, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Esomeprazole plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software.
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 44 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 period 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 period I of the study.
研究组 & 干预措施
Test product (T) 40 mg Hard Gelatin Capsules
Single oral dose of 40 mg capsule
干预措施: Test product (T) 40 mg Hard Gelatin Capsules (Drug)
Reference product (R) 40 mg Hard Gelatin Capsules (first dose)
Single oral dose of 40 mg capsule
干预措施: Reference product (R) 40 mg Hard Gelatin Capsules (Drug)
Reference product (R) 40 mg Hard Gelatin Capsules (second dose)
Single oral dose of 40 mg capsule
干预措施: Reference product (R) 40 mg Hard Gelatin Capsules (Drug)
结局指标
主要结局
Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))
时间窗: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
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")
Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))
时间窗: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
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)
Maximum plasma concentration (Cmax)
时间窗: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Cmax is observed as the maximum of Esomeprazole peak concentration
次要结局
- Maximum time (Tmax)(Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose)
- Elimination Rate Constant (Kel)(Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose)
- Plasma concentration half-life (t1/2)(Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose)
研究者
Hala Masoud
FRC Technical Director & CEO
Future University in Egypt