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An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Bosutinib Tablets 100 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with Bosulif (bosutinib) 100 mg, Manufactured and Packed by: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee, Freiburg, Germany, Imported by: Pfizer Brasil Ltda. Rodovia Presidente Castelo Branco, nº32501, km 32.5 CEP 06696-000 – Itapevi – SP, in healthy adult, human subjects under fed condition.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516489-12-00
Acronym
BOSUT-09-24
Enrollment
72
Registered
2024-12-16
Start date
2025-01-31
Completion date
2025-04-30
Last updated
2024-12-16

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

Conditions

myeloid leukemia

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