Healthy adult males
Conditions
Interventions
To confirm the effect of TW-4752N on the pharmacokinetics by applying a single TW-4752N (patch containing rivastigmine 51.84mg) to the anterior chest, following the application of the concomitant drug
Sponsors
Jun Miura
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult males aged 20 to 45 at the time of obtaining informed consent. 2. Subjects whose BMI is 18.5 or more and less than 25.0 at the time of the screening test (the second decimal position is truncated) 3. A person who are determined by the principal investigator as eligible subjects for the specified clinical study, taking into consideration of the applicant background, physical findings, vital signs, electrocardiogram, and clinical laboratory tests, etc. obtained from the screening test. 4. Subjects who have received sufficient explanation of the study drug/concomitant medication and the purpose and content of this specified clinical study (including subject limitations), and who have given written consent to participate in the study voluntarily.
Exclusion criteria
Exclusion criteria: 1. Subjects with myocardial infarction, valvular disease, cardiac diseases such as cardiomyopathy, electrolyte abnormalities (hypokalemia, etc.), or with a history of prolonged QT or its history/family history. 2. Subjects with skin diseases such as eczema, dermatitis, and pigmentary abnormalities. 3. Subjects with low body weight less than 50kg. 4. Subjects with disease currently being treated. 5. Subjects who used other drugs within 1 week before applying the study drug in Phase I.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC96 of unchanged objects in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, AUC from zero to infinity, tmax, MRT96 and kel of unchanged objects in plasma | — |
Contacts
Public ContactNakahara Masahiro
Sokujinkai kitahiroshima Hospital
Outcome results
None listed