Conditions: Asthma
Keywords: pharmacokinetics, pharmacodynamics, asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: yes

Brief summary:
Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.

Detailed description:

Arms:
arm 1: Subjects will be administered with SPARC1316 dose 1 arm 2: The subjects will receive placebo. arm 3: Subjects will be administered with SPARC1316 dose 2 arm 4: Subjects will be administered with SPARC1316 dose 3 arm 5: Subjects will be administered with SPARC1316 dose 4 arm 6: Subjects will be administered with SPARC1316 dose 5

Interventions: intervention 1: SPARC1316 Dose 1 intervention 2: Placebo intervention 3: SPARC1316 Dose 2 intervention 4: SPARC1316 Dose 3 intervention 5: SPARC1316 Dose 4 intervention 6: SPARC1316 Dose 5
Intervention descriptions: intervention 1: The subjects will receive SPARC1316. intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol document: