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A randomized, double-blind, single-center, 2-period cross-over Phase I study to assess the tolerability, safety and pharmacokinetics of antidepressant doses of oral ketamine hydrochloride prolonged release tablets (KET01) compared to intranasal esketamine in healthy male subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503971-45-00
Acronym
KET01-03
Enrollment
26
Registered
2023-05-19
Start date
2023-06-01
Completion date
2023-08-07
Last updated
2023-05-19

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

Conditions

Depression

Interventions

None listed

Sponsors

Ketabon GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 26, 2026