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 subject
ENZAL-16-24
Quick answer
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 subject for Prostate cancer is a Phase 1 program (other) at Pharma Mar S.A. with 1 ClinicalTrials.gov record(s).
Program details
- Company
- Pharma Mar S.A.
- Indication
- Prostate cancer
- Phase
- Phase 1
- Modality
- other
- Status
- active