None listed
Conditions
Interventions
Drug : - Randomization and numbering of subjects
Topical treatment allocation lists will be provided to the trial sites. Each subject will be assigned to one of the topical treatments based on his/her
Sponsors
Korea Otsuka Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has given his/her written informed consent to participate in the trial after receiving an adequate explanation of the trial and being given sufficient time to consider participation. 2. Subject is willing and able to comply with all trial requirements 3. Subject is a male or female and aged between 20 and 45 years of age (inclusive) 4. Subject is of normal body weight as determined by a body-mass index (BMI) between 18 and 28 kg/m2. 5. Subject is healthy as determined by EA (medical history, physical examination, skin evaluation, vital signs, ECG, hematology, clinical chemistry, urinalysis) 6. Subject is surgically sterile (i.e., has undergone orchidectomy if male or hysterectomy if female); subject has been postmenopausal for at least 12 consecutive months if female; or subject agrees to remain abstinent or to follow two acceptable methods of birth control from EA to the end of observation period. (fore male and female subjects) 7. Subject is Korean
Exclusion criteria
Exclusion criteria: 1. Subject has previously participated in this trial or any other trial with SPM 962 2. Subject has a history or complication of epilepsy and/or seizures. 3. Subject has clinically relevant changes in the ECG, such as second- or third-degree AV block, a complete bundle branch block, prolongation of the QRS complex over 120 ms, or of the QTcB (QT interval corrected for HR by Bazett´s formula) over 500 ms at EA confirmed by repeated measurement within 1 hour of the first recording 4. Subject has a clinically relevant hepatic dysfunction (total bilirubin concentration of >2 mg/dL [>34.2 µmol/L] or alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level more than 1.5 times the upper limit of the reference range [ULN]) 5. Subject has a clinically relevant renal dysfunction (serum creatinine >1.5 mg/dL) 6. Subject has a history of significant skin hypersensitivity to adhesives (e.g., plaster allergy) or other transdermal products or recent unresolved contact dermatitis 7. Subject has a history or complication of atopic or eczematous dermatitis, psoriasis, and/or an active skin disease or skin tumors 8. Subject has more than 1 known or suspected drug hypersensitivity, in particular to any component of the trial medication 9. Subject has a history of chronic alcohol or drug abuse within the last 5 years 10. Subject is tested positive for human immunodeficiency virus-1/2 antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) 11. Subject tests positive for alcohol (breath test) and/or drugs (urine test) at EA 12. Subject is taking any prohibited concomitant medication defined in “7.9 Concomitant Medication” 13. Subject has a history or complication of narrow angle glaucoma 14. Subject has a history or complication of respiratory or cardiovascular disorders (e.g., heart failure, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction) 15. Subject has a history or complication of psychic abnormality, psychiatric or neurologic illness, or autonomic neuropathy 16. Subject has a history or complication of diabetes mellitus and/or thyroid dysfunction, especially hyperthyroidism or other endocrine disorders. 17. Subject has a history or complication of malignancy 18. Subject has participated in another trial of an investigational product within the last 3 months or is currently participating in another trial of an investigational product 19. Subject is a female who is lactating or pregnant 20. The investigator or subinvestigator considers it difficult to secure the subject’s safety during the trial for any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin irritation score of the application site 24 hours after 2 mg/24 hr patch removal;Itching of application site evaluated by the visual analogue scale(VAS) 24 hours after 2 mg/24hr patch removal | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin irritation score after patch removal;Itching of application site evaluated by VAS after patch removal ;Time to event: Time from baseline (Day 3) to resolution of ASR after 48-hour SPM 962 administration | — |
Countries
Korea, Republic of
Contacts
Public ContactInbum Chung
Seoul National University Hospital
Outcome results
None listed