Trials / Completed
CompletedNCT03193203
Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
A Randomised, Open-label, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Etanercept | 50 mg/mL PFS and AI |
Timeline
- Start date
- 2017-03-24
- Primary completion
- 2017-08-07
- Completion
- 2017-08-07
- First posted
- 2017-06-20
- Last updated
- 2017-09-28
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03193203. Inclusion in this directory is not an endorsement.