An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy adult, human subjects under fed condition.
IVACA-05-23
Phase 1 other active
Quick answer
An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy adult, human subjects under fed condition. for Cystic Fibrosis 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
- Cystic Fibrosis
- Phase
- Phase 1
- Modality
- other
- Status
- active