Trials / Completed
CompletedNCT01953367
Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects
Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Pari Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects. Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vantobra (tobramycin) | Inhalation |
| DRUG | TOBI (tobramycin) | Inhalation |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2013-10-01
- Last updated
- 2014-04-25
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01953367. Inclusion in this directory is not an endorsement.