Multiple-dose Pharmacokinetics and Tolerability of "SYN006 HFA MDI" (Budesonide 180ug + Procaterol Hydrochloride 10ug/Dose HFA MDI) Administered Orally to Healthy Volunteers

Intech Biopharm Ltd.1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2012年11月最近更新: 2015年6月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Intech Biopharm Ltd.
入组人数: 16
试验地点: 1
主要终点: Area Under Curve (AUC) at day 1

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

Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is used as a bronchodilator in the management of reversible airways obstructive pulmonary disease. Budesonide and Procaterol therefore have complementary effects, treating two different components of asthma.

详细描述

Test drug: SYN006 HFA MDI Batch No: BPP-033-088 Dosage Form: HFA Metered Dose Inhaler Active Substance: Budesonide 180ug and procaterol hydrochloride hydrate 10ug/dose Dosage regimen: Multiple dose (4 puffs: budesonide 720ug and procaterol hydrochloride hydrate 40ug); thirteen consecutive doses

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
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

•Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
•Healthy adults, aged between 20 and 40 years old.
•Subjects with Body Mass Index (BMI) of >=18.5 and <=25.0 (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]).
•Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
•Clinical laboratory test: within limit of normal range or acceptable to investigator.

排除标准

•History of drug or alcohol abuse within the past year.
•Medical history of severe drug allergy or sensitivity to analogous drug.
•Evidence of acute or chronic diseases or having undergone surgery from 4 weeks prior to Period I dosing.
•Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology. Creatinine > 2UNL (upper normal limit); Liver enzymes > 2UNL; Total bilirubin > 2UNL.
•Planned vaccination during the time course of the study.
•Taking any clinical investigation drug from 2 months prior to Period I dosing.
•Use of any medication, including herb medicine from 4 weeks before dosing.
•Donation of 500mL of blood in the past 3 months prior to dosing or donation of 250mL of blood in the past 2 months prior to dosing.
•A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
•A positive test for HIV antibody.
•In screening subjects will be given training to ensure that subjects are able to correctly use the investigational products. If the subjects, the use of the investigational products lack of proficiency will not be included in this study.
•Students of National Defense Medical Center.
•For female subjects, if they meet any of the following criteria:
•Lactating women
•Positive pregnancy test (urine) at screening, or prior to dosing
•Do not use adequate contraception during the study
•Women taking oral contraceptives

研究组 & 干预措施

Budesonide/Procaterol 180/10 X 4 puffs

Experimental

Multiple dose of SYN006 HFA MDI (Budesonide 180ug + Procaterol 10ug/puff), 4 puffs each day for consecutive 7 days

干预措施: Budesonide/Procaterol 180/10 X 4 puffs (Drug)