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Clinical Trials/NL-OMON45782
NL-OMON45782
Completed
Not Applicable

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.

Hexal AG0 sites56 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Hexal AG
Enrollment
56
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Hexal AG

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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