At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
SPARC1316 Dose 1 +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
Sun Pharma Advanced Research Company Limited·interventional·Posted Jan 20, 2014·Updated May 23, 2016
In Brief
A Phase 2 clinical trial evaluating SPARC1316 Dose 1, Placebo, and 4 other interventions for Asthma. Completed, enrolled 64 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionNov 2014
TodayJul 2026
First PostedJan 20, 2014
Enrollment StartJan 1, 2014
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.5 years ago
Interventions
SPARC1316 Dose 1drug
The subjects will receive SPARC1316.
Placebodrug
SPARC1316 Dose 2drug
SPARC1316 Dose 3drug
SPARC1316 Dose 4drug
SPARC1316 Dose 5drug