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An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Brivaracetam Tablets Ph. Eur. 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Briviact (brivaracetam) 100 mg film-coated tablets, Marketing Authorisation Holder: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium; Manufactured by UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium, in healthy adult, human subjects under fasting condition.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516500-42-00
Acronym
BRIVA-10-24
Enrollment
36
Registered
2024-12-16
Start date
2025-03-13
Completion date
2025-04-10
Last updated
2024-12-16

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

Conditions

Epilepsy

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