2025-524311-37-00
Recruiting
Phase 4
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ponatinib Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Iclusig (Ponatinib hydrochloride) tablets 15 mg, Produced by: Patheon Inc. Mississauga, Canada or Takeda Ireland Limited Bray, Ireland, Imported and registered by: Pint Pharma Medical-Hospital and Pharmaceutical Products Ltd. Nelson Pontes Street, 125, Block 03, Jardim Margarida Zip Code 06739-024, Vargem Grande Paulista – SP CNPJ No. 21,896,000/0001-91, in healthy adult, human subjects under fasting condition.
Sun Pharmaceutical Industries Limited1 site in 1 country56 target enrollmentStarted: April 1, 2026Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Sun Pharmaceutical Industries Limited
- Enrollment
- 56
- 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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