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.

Sun Pharma Advanced Research Company Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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

发起方