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An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Lacosamide tablets USP 200 mg, manufactured by Sun Laboratories Industries Limited, India with Vimpat (Lacosamide) 200 mg film-coated tablets, Marketing Authorisation Holder UCB Pharma S.A., Belgium, in healthy adult, human subjects under fasting condition.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507991-32-00
Acronym
LACOS-06-23
Enrollment
32
Registered
2024-02-19
Start date
2024-07-25
Completion date
2024-09-03
Last updated
2024-02-19

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

Conditions

Epileptic seizures

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