Sialorrhea
Conditions
Sponsors
Miyoshi Katsunori
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subjects who have provided their own written informed consent 2) Subjects aged >=20 and =50 kg and body mass index (BMI) (kg/m2) of >=18.5 and <25.0 4) Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator
Exclusion criteria
Exclusion criteria: 1) Subjects who are suffering or have a history of any skin disease or skin abnormality at the site of study drug administration (postauricular area) that may prevent evaluation or are receiving treatment at the site of study drug administration that may prevent evaluation (e.g., topical corticosteroids) 2) Subjects who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or have a complication or a history of drug allergy 3) Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence 4) Subjects with a history of severe disease that may recur during the study period 5) Subjects with any concurrent illnesses such as angle closure glaucoma, open angle glaucoma, benign prostatic hyperplasia, urinary retention, severe heart disease, congestive heart failure, arrhythmia, paralytic ileus, pyloric stenosis, ileus, ulcerative colitis, asthma, hyperthyroidism, epilepsy, hepatitis, liver dysfunction or kidney dysfunction (however excluding diseases that will not affect study evaluations such as pollinosis without manifestations and verruca) 6) Subjects who received another study drug within 180 days prior to the start of study drug administration 7) Subjects who donated blood of >=400 mL within 12 weeks, blood of >=200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study 8) Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration 9) Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration 10) Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration 11) Subjects who smoked (used a product such as a cigarette, pipe, cigar, chewing tobacco, electronic cigarette, nicotine patch, or nicotine gum) within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period 12) Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening 13) Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening (e.g., Fridericia's corrected QT (QTcF) interval of >=450 ms) 14) Subjects who have serum electrolyte levels (potassium, calcium, and magnesium) lower than the institutional reference values 15) Subjects who have a familial history of Torsades de Pointes or long QT syndrome 16) Subjects who had blood pressure, pulse rate, or body temperature at screening as specified below (1) Systolic blood pressure =140 mmHg (2) Diastolic blood pressure =90 mmHg (3) Pulse rate =100 beats/min (4) Body temperature =37.degree 17) Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events, skin findings (based on the assessment criteria developed by the Japanese Study Group for Patch Testing), vital signs, 12-lead electrocardiogram (ECG) , laboratory test values and C-SSRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: Amount of salivation, salivation scores (assessed by subjects on the visual analog scale [VAS]) Pharmacokinetics: Plasma concentration of unchanged scopolamine, amount of excretion in the urine, the urine excretion rate and pharmacokinetic parameters (e.g., Cmax, C24h, tmax, AUC0-t and t1/2) Others: Amount of the drug remaining in the products that are collected after administration of NPC-22 Tape and adhesion state of NPC-22 Tape | — |
Contacts
Public ContactKatsunori Miyoshi
Nobelpharma Co., Ltd.
Outcome results
None listed