amyotrophic lateral sclerosis
Conditions
Interventions
Period1:The subjects were treated Scopolamin ointment(5%)in applied to post-auricular area once a daily with an adhesive plaster-wash-out period(more than one week)-Period2: The subjects were treated
Sponsors
Clinical Trial Center , Kitasato University East Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in this study have to fulfill all of following criteria and be judged eligible for the study by the investigator 1)Subjects must be able to understand the requirement of the study and must give a written, signed and dated informed consent before any study related activity is performed 2)Male subjects aged older than 20 and younger than 40 years old at timing of giving written informed consent 3)Subjects must be 50-100kg in weight and 18-27kg/m2 in BMI 4)Subjects must be judged eligible for inclusion in the study by the investigator after examining the investigators interview, physical and laboratory test
Exclusion criteria
Exclusion criteria: Subjects will be excluded from enrollment by the following criteria. The investigator must ensure the criteria basically at the timing of screening. 1) Subjects who have history of hypersensitivity to Scopolamin /Atropin (Belladonna alcaloid) 2) Subjects who are prohibited the use of Scopolamin hydrobromide as follows ; (a) glaucoma (b)Prostatic hypertorophy with dysuria (c)Clinical significant heart disease (d)Paralytic ileus (e)A known hypersensitivity to the study drug or the ingredient of the study drug (f)History or clinical evidence of Asthma (g)History or clinical evidence of Hepatitis 3) Subjects with underlyimg condition (renal or hepatic ) that need treatment 4)Subjects may be administrated anticholinergic agent or dopaminergic antagonist during this study, the opinion of the investigator would not be judged eligible for the enrollment of this study 5)Subjects that in the opinion of the investigator would not be judged eligible for the enrollment of the study based on the mode of action of the investigational drug 6)Subjects took a drug containing Scopolamin or health food containing St.Johns wort within 14days before dosing and be judged not eligible for the enrollment of the study by the investigator 7) Subjects who took food and drink containing grapfruits 7 days prior to dosing 8) Use of investigational treatment within 3 months before the time of enrollment 9) Domation or loss of 200 mL or more blood within a month prior to participation, domation or loss of 400 mL or more blood within 3 months prior to participation 10) A positive Syphilis test result, Hepatitis B surface antigen or Hepatitis C 11) History of drug or alcohol abuse or evidence of such abuse as indicated by the laboratory assays conducted the screening or baseline evaluations. 12) Subjects that in the opinion of the investigator would not be judged eligible for the enrollment of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Plasma concencentrations of unchanged Scopolamin, urinary excretion rates and pharmacokinetic parameters (Cmax, Tmax, AUC and halflife time) | — |
Countries
Japan
Contacts
Public ContactMika Maeda
Kitasato University East Hospital Clinical Trial Center
Outcome results
None listed