Trials / Completed
CompletedNCT02041221
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Sun Pharma Advanced Research Company Limited · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPARC1316 Dose 1 | The subjects will receive SPARC1316. |
| DRUG | Placebo | |
| DRUG | SPARC1316 Dose 2 | |
| DRUG | SPARC1316 Dose 3 | |
| DRUG | SPARC1316 Dose 4 | |
| DRUG | SPARC1316 Dose 5 |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2014-01-20
- Last updated
- 2016-05-23
- Results posted
- 2016-03-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02041221. Inclusion in this directory is not an endorsement.