Trials / Completed
CompletedNCT02991261
Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Sun Pharma Advanced Research Company Limited · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPARC001 type I | Treatment type I |
| DRUG | SPARC001 type II | Treatment type II |
| DRUG | Reference001 type I | Hydrocodone-acetaminophen |
| DRUG | Reference001 type II | Hydrocodone Acetaminophen |
Timeline
- Start date
- 2017-02-06
- Primary completion
- 2017-03-15
- Completion
- 2017-04-01
- First posted
- 2016-12-13
- Last updated
- 2019-05-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02991261. Inclusion in this directory is not an endorsement.