A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, 3-WAY CROSSOVER STUDY TO COMPARE THE RATE AND EXTENT OF RIVASTIGMINE ABSORPTION FROM A 7 DAY RIVASTIGMINE TRANSDERMAL SYSTEM (7-DAY RTS) WITH AND WITHOUT OVERLAY WITH 24-HR EXELON® PATCH APPLIED DAILY FOR 7 DAYS IN HEALTHY MALE AND FEMALE SUBJECTS

A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, 3-WAY CROSSOVER STUDY TO COMPARE THE RATE AND EXTENT OF RIVASTIGMINE ABSORPTION FROM A 7 DAY RIVASTIGMINE TRANSDERMAL SYSTEM (7-DAY RTS) WITH AND WITHOUT OVERLAY WITH 24-HR EXELON® PATCH APPLIED DAILY FOR 7 DAYS IN HEALTHY MALE AND FEMALE SUBJECTS - Rivastigmine transdermal patch study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38506

Enrollment

Registered

2013-04-03

Start date

2013-04-08

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

dementia

Interventions

On Day 1 of each period RTS or Exelon® will be applied after a fasting period (no food or drinks) of at least 10 hours. The transdermal patches will be applied to your upper back. Per period you wil

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female subjects 18-65 yrs, inclusive BMI: 18.0-29.9 kg/m2, inclusive non-smoking light skin color

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 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
Pharmacokinetics: plasma concentrations and PK parameters Dermal evaluations, patch adhesion, amount of adhesive residue application site, difficulty of patch removal, residual drug analysis Safety: AEs, vital signs, ECG, clinical laboratory assessments, physical examination	—

Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)