A single-center, open-label, randomized, 3-way crossover study to compare the rate and extent of Rivastigmine absorption from two different formulations of 7 day Rivastigmine transdermal systems (7-day RTS) with 24-hour Exelon® patches 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 two different formulations of 7 day Rivastigmine transdermal systems (7-day RTS) with 24-hour Exelon® patches 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-OMON40916

Enrollment

Registered

2014-03-27

Start date

2014-04-16

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

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 the upper back. Per period the volu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, 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 90 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: AE's, vital signs, ECG, clinical laboratory assessments, physical examination.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)