Single-site, open-label, randomized, crossover study in healthy subjects to evaluate bioequivalence of rotigotine transdermal patches (2mg/24H) from 2 different manufacturing sites

Single-site, open-label, randomized, crossover study in healthy subjects to evaluate bioequivalence of rotigotine transdermal patches (2mg/24H) from 2 different manufacturing sites - Rotigotine transdermal patch bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42064

Enrollment

Registered

2014-11-18

Start date

2015-01-11

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

Parkinson Restless Legs Syndrome

Interventions

In this study you will receive 2 different treatments: Treatment A: 1 rotigotine transdermal patch from the *new* manufacturing site containing 2 milligrams of rotigotine applied for 24 hours on the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female subjects 18-55 yrs, inclusive BMI: 19.0-28.0 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
To investigate and compare the relative bioavailability (BA) and single-dose pharmacokinetics (PK) of rotigotine transdermal patches from 2 different manufacturing sites to establish BE.	—

Secondary

Measure	Time frame
To investigate the safety, tolerability, and adhesiveness of rotigotine transdermal patches from the 2 different manufacturing sites.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)