A Pilot Open-label, Randomized, Crossover, Comparative Bioavailability Study of Levodopa Administered via Levodopa Cyclops™ (test product) Relative to INBRIJA® (reference product) in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504687-42-00

Acronym

CPI23001

Enrollment

Registered

2023-08-15

Start date

2023-09-19

Completion date

2023-11-09

Last updated

2023-08-15

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

Conditions

No therapeutic indication in the current trial with healthy volunteers. The intended indication is for intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Countries

Bulgaria

Outcome results