A randomized, open-label, two-period, two-sequence, single-dose, cross-over study to compare the pharmacokinetics, safety, and tolerability of the auto injector and pre-filled syringe of SB4 in healthy male subjects.
Completed
- Conditions
- Auto immune diseases10003816
- Registration Number
- NL-OMON45442
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
healthy male subjects
18 - 55 years of age, inclusive
BMI 20.0 - 28.0 kg/m2, inclusive
weight 60.0 - 85.5 kilograms, inclusive
non-smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to demonstrate bioequivalence of the pharmacokinetic<br /><br>(PK) profiles between SB4 Autoinjector (AI) and SB4 Pre-filled syringe (PFS)<br /><br>based on AUCinf, AUClast and Cmax in healthy male subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to investigate the safety and tolerability between<br /><br>SB4 AI and SB4 PFS in healthy male subjects.</p><br>