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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.

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524267-20-00
Enrollment
72
Registered
2026-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma (in combination with dabrafenib);, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib;, BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC);, BRAF V600E mutation-positive low-grade glioma (LGG)., BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC), BRAF V600E mutation-positive unresectable or metastatic solid tumors;, BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, in combination with dabrafenib;

Interventions

None listed

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Outcome results

None listed

Source: EU CTIS · Data processed: May 1, 2026