Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

Inclusion Criteria:

• Subjects willing to provide informed consent

• Male or female subjects aged 18 to 65 years inclusive

• Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive

• Non-smokers or ex-smokers

Exclusion Criteria:

• Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg

• Subjects who have a significant infection or known inflammatory process on screening or admission.

• Subjects who are unlikely to co-operate with the requirements of the study.

• Positive serology for infectious disease (hepatitisB or C , HIV) at screening