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An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ruxolitinib Tablets, 20 mg, manufactured by Sun Pharmaceutical Industries Limited, India with JAKAVI (ruxolitinib) tablets 20 mg, (each Jakavi 20 mg tablet contains 26.40 mg of ruxolitinib phosphate equivalent to 20 mg of ruxolitinib). Imported by: Novartis Biociências SA Av. Prof. Vicente Rao, 90 - São Paulo - SP CNPJ: 56.994.502/0001-30. Manufactured by: Novartis Pharma Stein AG, Stein – Switzerland, in healthy adult, human subjects under fasting condition.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519801-36-00
Acronym
RUXOL-18-24
Enrollment
40
Registered
2025-06-23
Start date
2025-07-14
Completion date
2025-08-11
Last updated
2025-06-23

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

Conditions

acute and chronic graft-versus-host-disease., Myelofibrosis, polycythemia vera

Interventions

None listed

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

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