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A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 10 mg, manufactured by Ohm Laboratories Inc. (A Sun Pharma Company), 14 Terminal Road, New Brunswick, 08901, NJ, USA with Vyvanse (Lisdexamfetamine Dimesylate) 10 mg capsules; Product of Takeda Canada Inc., Toronto Ontario ON M5H 4E3, Canada, in healthy adult, human subjects under fasting condition.

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517956-36-00
Acronym
LISDE-14-24
Enrollment
64
Registered
2025-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

ADHD

Interventions

None listed

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

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