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.

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. - Erelzi/Enbrel bioequivalence study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45782

Enrollment

Registered

2018-06-20

Start date

2019-06-18

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To demonstrate PK similarity between Erelzi LYVI/US and Enbrel LYVI/US following a single s.c. injection of 18 mg.	—

Secondary

Measure	Time frame
- To compare additional PK parameters between Erelzi LYVI/US and Enbrel LYVI/US following a single s.c. injection - To evaluate and compare the immunogenicity of both products - To evaluate and compare the safety, tolerability and injection site reactions (ISR) of both products	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)