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An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Naltrexone hydrochloride film-coated tablet, 50 mg, manufactured by Sun Pharmaceutical Industries Limited, India with NALTREXONE GH (naltrexone hydrochloride) film-coated tablets 50 mg, Product of Generic Health Pty Ltd Suite 2, Level 2 19-23 Prospect Street Box Hill, VIC, 3128, Australia, in healthy adult, human subjects under fasting condition.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519776-20-00
Acronym
NALTR-17-24
Enrollment
72
Registered
2025-04-28
Start date
2025-05-12
Completion date
2025-06-13
Last updated
2025-04-28

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

Conditions

Alcohol dependence

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