A randomized, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjects
- Conditions
- autoimmune diseasesrheumatoid arthritis10003816
- Registration Number
- NL-OMON40923
- Lead Sponsor
- Hexal AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
- Subjects must give written informed consent before any assessment is performed;- Male subjects, aged 18 to 55 years inclusive ;- Physically and mentally healthy, as determined by physical examination and safety laboratory;- Body weight between 50 to 140 kg and body mass index (BMI) between 18.5 to 49.9 kg/m2 inclusively;- Non-smoker or ex-smoker, defined as not having smoked for at least 6 months before IMP administration
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>Bioequivalence</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics and safety and tolerability.</p><br>