NCT02543606已完成4 期
A Randomized, Two-way Crossover, Single-dose Pharmacokinetic Study to Evaluate the Bioequivalence of Esomelone for Injection/Infusion (Esomeprazole 40mg), Compared to Reference Drug (Nexium 40mg) in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The pharmacokinetic parameters of ln transformed data ln(AUC) of the product.
研究概览
简要总结
Bioequivalence of Two Formulations of Esomeprazole 40mg
详细描述
A randomized, two-way crossover, single-dose pharmacokinetic study to evaluate the bioequivalence of a test formulation of Esomelone powder for solution for injection/infusion 40mg (Esomeprazole 40mg), compared to an equivalent dose of a reference drug product (Nexium powder for injection and infusion 40mg) in healthy adult subjects.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult, aged between 20 to 40 years old.
- •Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.
- •no particular clinical significance in clinical examination and laboratory tests within two months (60 days) prior to Period I dosing.
- •normal or considered not clinically significant by the investigator chest X-ray and ECG results within six months (180 days ) prior to Period I dosing.
- •The normal range of the body mass index should be between 18.5 and 25; body mass index equals [weight (kg)]/[height (m)]
- •Normal laboratory determinations result (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.
- •Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.
- •Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.
- •Female subject who is
- •using adequate contraception since last menstruation and no plan for conception during the study,
- •non-lactating.
- •has negative pregnancy test (urine) within 14 days prior to the study.
- •Informed consent form signed.
排除标准
- •A history of drug or alcohol abuse during the past 24 weeks.
- •Sensitivity to analogous drug.
- •A clinically significant illness (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, melaena or gastric ulcer) within the past 4 weeks.
- •Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
- •Planned vaccination during the time course of the study.
- •Participation of ant clinical investigation during the last 60 days.
- •Regular use of any medication during the last 4 weeks.
- •Single use of any medication during the last 2 weeks.
- •Blood donation of more than 250 mL within the past 12 weeks.
- •Individuals are judged by the investigation or co-investigator to be undesirable as subjects.
研究组 & 干预措施
Esomelone
Experimental
powder for injection/ infusion Esomeprazole 40mg
干预措施: Esomelone (Drug)
Esomelone
Experimental
powder for injection/ infusion Esomeprazole 40mg
干预措施: Nexium (Drug)
Nexium
Active Comparator
powder for injection/ infusion Esomeprazole 40mg
干预措施: Esomelone (Drug)
Nexium
Active Comparator
powder for injection/ infusion Esomeprazole 40mg
干预措施: Nexium (Drug)
结局指标
主要结局
The pharmacokinetic parameters of ln transformed data ln(AUC) of the product.
时间窗: pre-dose to 12 hours post dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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