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2025-524267-20-00Not yet recruitingPhase 1

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.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Apr 2026

Next steps

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
72 (estimated)
First submitted
19 Jan 2026
Start date
1 Sept 2026
Lead sponsor
Sun Pharmaceutical Industries Limited
EU CT number
2025-524267-20-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 72
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adult volunteers to compare two trametinib 2 mg tablets, each taken as a single dose while fasting.

Age
18 to 64 years
Sex
Men and women can join.

This trial only enrols healthy participants. The registry sentence this rests on: healthy, adult, human subjects under fasting condition

Read by machine on 9 Nov 2026.

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Terapia S.A.Cluj-NapocaRomaniaNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.