2024-518209-16-00
Recruiting
Phase 1
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 80 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.
Sun Pharmaceutical Industries Limited1 site in 1 country40 target enrollmentStarted: April 2, 2025Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
Overview
Brief Summary
No summary available.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Investigators
Arshad Khuroo
Scientific
Sun Pharmaceutical Industries Limited
Study Sites (1)
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