A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Palonosetron After Intravenous Administration of Palonosetron in Healthy Volunteers Under Fasting Conditions

Yung Shin Pharm. Ind. Co., Ltd.1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2020年8月17日最近更新: 2021年8月4日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Yung Shin Pharm. Ind. Co., Ltd.
入组人数: 16
试验地点: 1
主要终点: Peak concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: None

入排标准

年龄范围: 20 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
•Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
•Acceptable medical history and physical examination including:
•no particular clinically significant abnormalities in ECG results within six months prior to Period I dosing.
•no particular clinical significance in general disease history within two months prior to Period I dosing.
•Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes AST (SGOT), ALT (SGPT), γ-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride (TG).
•Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
•Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin and protein.
•Female of childbearing potential practicing an acceptable method of birth control for the duration of the study.
•Have signed the written informed consent to participate in the study.

排除标准

•A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
•A clinically significant illness or surgery within four weeks prior to Period I dosing.
•History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
•History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
•Known or suspected history of drug abuse within lifetime.
•History of alcohol addiction or abuse within last five years or use of more than 7 units of alcohol per week within two weeks prior to dosing. (1 unit of alcohol = 10 g of alcohol or about 350 mL of beer or about 83 mL of red wine or about 30 mL of beverage containing 40% (v/v) alcohol).
•History of allergic response(s) to palonosetron or any other related drugs.
•Evidence of chronic or acute infectious diseases.
•Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
•Female subjects demonstrating a positive pregnancy screen prior to the study.
•Female subjects who are currently breastfeeding.
•Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine.
•Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to Period I dosing.
•Use of any investigational drug within four weeks prior to Period I dosing.
•Donating more than 250 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing.
•Any other medical reason as determined by the investigator.

研究组 & 干预措施

Palonosetron (Stothu®)

Experimental

Stothu® Solution for Injection 0.25 mg/5 mL

干预措施: Palonosetron (Drug)

Palonosetron (Aloxi®)

Active Comparator

Aloxi® Solution for Injection 0.25 mg/5mL

干预措施: Palonosetron (Drug)

结局指标

主要结局

Peak concentration (Cmax)

时间窗: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose