A Randomized, Double-Blind, Crossover, Comparative Pharmacokinetic Trial of Deulevodopa (TEV-50939) and Levodopa, both Administered with Carbidopa in Healthy Subjects

A Randomized, Double-Blind, Crossover, Comparative Pharmacokinetic Trial of Deulevodopa (TEV-50939) and Levodopa, both Administered with Carbidopa in Healthy Subjects - TEV-50939 and Levodopa comparative study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42683

Enrollment

Registered

2015-12-15

Start date

2015-12-28

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

movement disorder

Interventions

During the study the subject will receive the study compound after an overnight fast (at least 10 hours no eating and drinking). In Period 1, the subject will receive a single dose of 37.5 mg carbid

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female subjects - 25-40 yrs, inclusive - BMI: 18.5-30.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
safety, PK, tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)