A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area Under the Concentration Versus Time Curve (AUClast)
研究概览
简要总结
This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients with chronic obstructive pulmonary disease (COPD).
详细描述
Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 8 A.M. in the morning of the drug administration day, followed by blood collection for evaluation of pharmacokinetics. The same schedule with increased dose will be proceeded after 14-day washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 to 45, healthy male subjects (at screening)
- •Body weight between 55kg - 90kg, BMI (Body Mass Index) between 18.0 - 27.0
- •Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent
排除标准
- •Volunteer who has past or present history of any diseases such as liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder
- •Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
- •Subject who already participated in other trials in 3 months
- •Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
研究组 & 干预措施
Inhalation of HCP0910 and HGP1011
Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days.
干预措施: HCP0910 and HGP1011 (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve (AUClast)
时间窗: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration
次要结局
- Time to Maximum Concentration (Tmax)(Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose)
- Maximum Observed Concentration (Cmax)(Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose)
研究者
In-Jin Jang, MD, PhD
Clinical pharmacology and therapeutics
Seoul National University Hospital