An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Trametinib tablets 2 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with MEKINIST® (Trametinib) tablets 2 mg, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA in healthy, adult, human subjects under fasting condition.
TRAME-13-25
Quick answer
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Trametinib tablets 2 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with MEKINIST® (Trametinib) tablets 2 mg, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA in healthy, adult, human subjects under fasting condition. for Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma (in combination with dabrafenib);, BRAF V600E mutation-positive unresectable or metastatic solid tumors;, BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC), in combination with dabrafenib;, BRAF V600E mutation-positive low-grade glioma (LGG)., BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC);, BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib; 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
- Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma (in combination with dabrafenib);, BRAF V600E mutation-positive unresectable or metastatic solid tumors;, BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC), in combination with dabrafenib;, BRAF V600E mutation-positive low-grade glioma (LGG)., BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC);, BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib;
- Phase
- Phase 1
- Modality
- other
- Status
- active