A randomized, open-label, two-period, crossover study to determine the pharmacokinetics of reconstituted lyophilized Erelzi and Enbrel® (US-licensed) following a single subcutaneous injection in healthy male subjects.
Completed
- Conditions
- rheumatoid arthritis10023213
- Registration Number
- NL-OMON45782
- Lead Sponsor
- Hexal AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
Inclusion Criteria
Male subjects
18 to 55 years, inclusive
Weight 50 - 99.9 kg
BMI 19.0 - 29.9 kg/m2 inclusive ;5. Subject is affiliated with social security or equivalent system
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>To demonstrate PK similarity between Erelzi LYVI/US and Enbrel LYVI/US<br /><br>following a single s.c. injection of 18 mg.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To compare additional PK parameters between Erelzi LYVI/US and Enbrel LYVI/US<br /><br>following a single s.c. injection<br /><br>- To evaluate and compare the immunogenicity of both products<br /><br>- To evaluate and compare the safety, tolerability and injection site reactions<br /><br>(ISR) of both products</p><br>