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An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 160 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subjects under fasting condition.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518211-20-00
Acronym
ENZAL-16-24
Enrollment
40
Registered
2025-04-02
Start date
2025-04-14
Completion date
2025-08-11
Last updated
2025-04-02

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

Conditions

Prostate cancer

Interventions

None listed

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

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