CTRI/2013/08/003878已完成1/2 期
A randomized, open label, two treatment, two period, two sequence, single dose, crossover, comparative pharmacokinetic & pharmacodynamic study of salmeterol 25 mcg and fluticasone propionate 250 mcg inhalation powder (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and seretidetm diskus 50/500 (salmeterol 50mcg and fluticasone propionate 500mcg) inhalation powder of Glaxosmithkline in moderate to severe asthmatic patients.
适应症
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax,AUC, Tmax, t½
研究概览
简要总结
The study was conducted to to monitor the safety of the subjects participating in the study and to assess the comparative pharmacokinetic & pharmacodynamic of Salmeterol 25mg + Fluticasone Propionate 250mg Inhalation Powder (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and SeretideTM Diskus 50/500 (Salmeterol 50mg + Fluticasone Propionate 500mg) Inhalation Powder of GlaxoSmithKline in moderate to severe asthmatic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Eighteen years or older moderate to severe asthmatic subjects with weight at least 50 kg and BMI between 18.5-3.0 kg/m2 subjects who are willing to sign written consent form prior to study entry subjects with clinically acceptable results from the screening procedure including blood pressure, pulse rate, 12-lead ECG, x-ray, physical examination, medical history, hematology, biochemistry, urinalysis and infection screen (Hepatitis C Antibody, HIV) Diagnosis of asthma.
排除标准
- •Subjects with a history of clinically significant gastrointestinal, dermatological, cardiovascular, renal, hematological, psychiatric, cerebrovascular, neurological, hepatic, pulmonary (significant respiratory disease other than asthma), or endocrine disease in the last 12 months; Allergy or Significant history of hypersensitivity or idiosyncratic reactions to fluticasone and/ or salmeterol, milk proteins and /or any related compounds etc; Subjects determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results.
- •(E.g. history of surgery of the gastro-intestinal tract, which may interfere with absorption, except for appendectomy); Females who are pregnant, breastfeeding, or are likely to become pregnant; Subjects with any clinically significant illness (including respiratory illness) within 4 weeks prior to Period 1 dosing, and Diagnosis of COPD.
结局指标
主要结局
Cmax,AUC, Tmax, t½
时间窗: 1h predose, 1min, 3min, 5min, 10min, 30min, 60min, 90min, 2h, 3h, 4h, 8h, 12h and 36h postdose
次要结局
- Safety parameters(at pre-dose and1, 2, 4 and 12 hours post-dose)
研究者
研究点 (1)
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