An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 70 mg, manufactured by Sun Pharmaceutical Industries Limited, India with VENVANSE (lisdexamfetamine dimesylate) 70 mg Hard Gelatin Capsule, imported and registered by: Takeda Pharma Ltd. Rodovia SP 340 S/N, km 133.5, Ed. Adm. Jaguariúna-SP CNPJ 60.397.775/0001-74 and manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, United States of America or Takeda Pharma Ltd. Rodovia SP 340 S/N, km 133.5, Ed. QC - Jaguariúna – SP, Brazilian industry in healthy adult, human subjects under fasting condition.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521224-29-00

Acronym

LISDE-01-25

Enrollment

Registered

2025-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-30

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

Conditions

ADHD (Attention Deficit Hyperactivity Disorder), BED (Binge Eating Disorder)

None listed

Sex/Gender

All

Age

18 Years to 64 Years

Romania

None listed

Source: EU CTIS · Data processed: Feb 4, 2026