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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051210024

Registered date:11/05/2021

Investigation of the Food Effect on the Pharmacokinetics of JT408T

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedImprovement of neurological symptoms of Gaucher's disease
Date of first enrollment10/06/2021
Target sample size16
Countries of recruitment
Study typeInterventional
Intervention(s)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.

Outcome(s)

Primary OutcomeThe incidence of adverse events and side effects
Secondary OutcomePharmacokinetic - Serum JT408T concentrations - Pharmacokinetic parameters

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 35age old
GenderMale
Include criteria1) Personally provided written voluntary informed consent to participate in the study 2) Japanese men aged >= 20 and < 35 years at the time of informed consent 3) BMI >= 18.5 and < 25.0 kg/m2 and Weight >=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.
Exclude criteria1) 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.

Related Information

Contact

Public contact
Name Shunichiro Yutaka
Address 2-4 Kasuga-cho, Ashiya, Hyogo Hyogo Japan 659-8582
Telephone +81-797-32-8582
E-mail clinical_development@jp.jcrpharm.com
Affiliation JCR Pharmaceuticals Co., Ltd.
Scientific contact
Name Shunichiro Yutaka
Address 2-4 Kasuga-cho, Ashiya, Hyogo Hyogo Japan 659-8582
Telephone +81-797-32-8582
E-mail clinical_development@jp.jcrpharm.com
Affiliation JCR Pharmaceuticals Co., Ltd.