Pharmacology study of SUN Pharmas Dry powder inhaler in patients with moderate to severe asthma

• Conditions: Other and unspecified asthma,

• Registration Number: CTRI/2014/07/004752
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

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 However, due to slow rate of recruitment, the study is withdrawn.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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-28
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC 0-t , Cmax	24-hours post dose

Secondary Outcome Measures

Name	Time	Method
AUC0-inf, tmax, t1/2, Kel	24 hours pre-dose and up to 24 hours post-dose

Trial Locations

Locations (1)

Grant Medical College and Sir J.J. Group of Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Grant Medical College and Sir J.J. Group of Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Ramraje Nagsen Nirgun

Principal investigator

91-9825985265

akash.khobragade@gmail.com