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An open-label, randomized, single-dose, two-period, two-treatment, crossover bioequivalence study with GP-IMP-001 in healthy male volunteers under fasting conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522921-37-00
Enrollment
36
Registered
2025-09-11
Start date
2025-10-22
Completion date
2026-01-06
Last updated
2025-09-11

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

Conditions

active juvenile idiopathic arthritis, either alone or in combination with corticosteroids, in adult patients refractory or intolerant to thiopurines., inteneded for treatment of - active rheumatoid arthritis in adult patients, - mild-to-moderate Crohn’s disease, - polyarthritic forms of severe, - severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy and severe psoriatic arthritis in adult patients, when the response to nonsteroidal anti-inflammatory drugs has been inadequate

Interventions

None listed

Sponsors

Gebro Pharma GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026