Improvement of neurological symptoms of Gaucher's disease
Conditions
Interventions
1) After fasting, administer 400 mg of ambroxol hydrochloride orally in a single dose.
2) After meals, administer 400 mg of ambroxol hydrochloride orally in a single dose.
Sponsors
Yutaka Shunichiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Personally provided written voluntary informed consent to participate in the study 2) Japanese men aged >= 20 and = 18.5 and =50.0kg <75.0kg at screening 4) Patients who can agree to the contraception from the start JT408T administration to the time of final observation. And patients who can agree not to donate sperm for the purpose of fertilization, etc.
Exclusion criteria
Exclusion criteria: 1) Persons who have abnormal findings in medical examinations and various tests, and the investigator has determined that there is a clinical problem. 2)Persons with complications or medical history that are considered inappropriate for participation in this study. (Liver disorder, renal disorder, cardiovascular disease, endocrine system disease, metabolic disease, respiratory system disease, neurological disease, urinary system disease, immune system disease, psychiatric disease, etc.) 3)Persons who have or have a history of allergies to drugs or food, or who are suspected of having any of them 4)Persons who have been diagnosed with malignant tumors (including those who have a history within 5 years before obtaining consent) 5)Persons who have undergone surgical operations that are known to affect the gastrointestinal absorption of drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic - Serum JT408T concentrations - Pharmacokinetic parameters | — |
Contacts
Public ContactShunichiro Yutaka
JCR Pharmaceuticals Co., Ltd.
Outcome results
None listed