A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Voriconazole(200mg/Vial) After Intravenous Infusion of 200mg Voriconazole 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 14 人开始时间: 2020年6月13日最近更新: 2020年9月17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: 14
试验地点: 1
主要终点: Ratio of AUC 0-t to AUC 0-∞

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 Voriconazole(200mg/Vial) After Intravenous Infusion of 200mg Voriconazole in Healthy Volunteers Under Fasting Conditions.

研究设计

研究类型: Interventional
分配方式: Non 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 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 weight within 80-120% of ideal body weight but not less than 45kg at the screening visit.
•Ideal body weight (kg) = [height (cm) - 80] ´ 0.7 for male subjects
•Ideal body weight (kg) = [height (cm) - 70] ´ 0.6 for female subjects
•Acceptable medical history and physical examination including:
•no particular clinically significant abnormalities in Electrocardiogram(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 ASpartate aminoTransferase (AST), ALanine aminoTransferase (ALT), Gamma-Glutamyl-Transpeptidase (g-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 this study.

排除标准

•A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the investigator).
•A clinically significant illness or surgery within four weeks prior to Period I dosing (as determined by the investigator).
•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 as judged by the investigator.
•History of alcohol addiction or abuse within last five years as judged by the investigator.
•History of allergic response(s) to voriconazole, any other drugs analogous to voriconazole, or any antibiotics.
•Evidence of chronic or acute infectious diseases.

研究组 & 干预措施

Vaway Lyo-Injection

Experimental

Voriconazole, 200 mg/vial

干预措施: Vaway (Drug)

Vfend Lyo-Injection

Active Comparator

Voriconazole, 200 mg/vial

干预措施: Vaway (Drug)

结局指标

主要结局

Ratio of AUC 0-t to AUC 0-∞

时间窗: 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours