A RANDOMIZED, OPEN LABEL, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE,SINGLE DOSE, CROSSOVER, COMPARATIVE PHARMACOKINETIC &PHARMACODYNAMIC STUDY OF SALMETEROL 25mg and FLUTICASONE PROPIONATE 250mgDRY POWDER INHALER (SUN DPI) OF SUN PHARMA ADVANCED RESEARCH COMPANYLIMITED, INDIA AND SERETIDETM ACCUHALERTM 50/500 (SALMETEROL 50mg andFLUTICASONE PROPIONATE 500mg) DRY POWDER INHALER OF GLAXOSMITHKLINE INMODERATE TO SEVERE ASTHMATIC PATIENTS.

Sun Pharma Advanced Research Company Limited1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2014年11月28日最近更新: 2019年8月7日

适应症

试验速览

阶段: 不适用
状态: Other
发起方: Sun Pharma Advanced Research Company Limited
入组人数: 36
试验地点: 1
主要终点: AUC 0-t , Cmax

研究概览研究设计入排标准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

The objective of the study is to monitor the safety of the subjects participating in the study and to assess the comparative pharmacokinetics & pharmacodynamics of Salmeterol 25mg and Fluticasone Propionate 250mg Dry Powder Inhaler (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and SeretideTM AccuhalerTM 50/500 (Salmeterol 50mg and Fluticasone Propionate 500mg) Dry Powder Inhaler. However, due to slow rate of recruitment, the study is withdrawn. No patient is enrolled in the study

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 0.00 Year(s)（—）
性别: All

入选标准

•Asthmatic subjects, 18 years of age or older -Having no evidence of underlying disease (except asthma) -Willing to sign the informed consent form -Ability to use the dry powder inhaler correctly.

排除标准

•Having history of clinically significant gastrointestinal, dermatological, cardiovascular, renal, hematological, psychiatric, cerebrovascular, neurological, hepatic, pulmonary -Having hypersensitivity or allergy to ingredients of the IP -Subjects determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results -Females who are pregnant, breastfeeding, or are likely to become pregnant.

结局指标

主要结局

AUC 0-t , Cmax

时间窗: 24-hours post dose

次要结局

AUC0-inf, tmax, t1/2, Kel(24 hours pre-dose and up to 24 hours post-dose)

研究者

发起方

Sun Pharma Advanced Research Company Limited

申办方类型

Pharmaceutical industry-Indian

研究点 (1)

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