臨床研究等提出・公開システム

Administration study of lomerizine to healthy adult males

Administration study of lomerizine to healthy adult males

10

Japanese healthy adult male

No adverse events were observed.

Blood and urine Samples were properly collected with respect to time, type, and volume of sampling to ascertain the effects of different sampling methods.

Blood and urine samples were collected appropriately for the time, type, and volume of collection to verify the detectable period of unchanged drug and metabolites of the study drug.

An oral dose of 15 mg （three Migsis® Tablets 5mg）was administered to 10 male volunteers, after which urine samples collected during the following 276 hours were analyzed using the developed method, allowing for examination of the target analytes' excretion profile. We obtained to investigate the detectable period of the unchanged form and metabolites of the test drug after administration.

Oct. 17, 2018

https://pubmed.ncbi.nlm.nih.gov/30240154/

Takazawa Kenji

Medical Corporation Shinanokai Shinanozaka Clinic

Yotsuya Medical Bldg.3F, 20, Samon-cho, Shinjuku-ku, Tokyo, Japan

chiken-contact1@shinanokai.com

Sato Mitsuhiko

LSI Medience Corporation

1-15-10 Shimura Itabashi-ku Tokyo, Japan

+81-3-5994-2351

satou.mitsuhiko@ma.medience.co.jp

completed

Interventional

After a preliminary examination (Items: medical history, current medical history, and safety confirmation) on Japanese healthy adult men within 30 days before the test drug administration, 10 of them as subjects are administered it in an open-label manner and sample collection on the subjects are conducted. Each sample is managed according to the protocol and to quantitative analysis of the unchanged form and metabolites of the test drug.

other

N/A

The weight (kg) / height (m) 2 :18.5 or more and less than 25.0 at the time of a prior inspection. There is consent to clinical test participation.

Nationality Japanese

1. A person who had shown symptoms of allergy caused by this test drug or its composition.
2. A person who is suffering from Intracranial hemorrhage, cerebral infarction, liver disease, Parkinson's disease, depression and who is suspected to have these diseases.
3. A history of alcohol or drug addiction,
4. Under the medical treatment or it may treat of a certain disease,
5. Ethical or OTC pharmaceuticals administered within two weeks before scheduled administration of the study drug, Supplement, grapefruit or its products, or foods coating Western St. John's consumed within one week before scheduled administration of the study drug.
6. Not less than 200mL of blood is collected within 30 days or not less than 400mL of blood is collected within 90 days before scheduled administration of the study drug.
7. Weight: less than 50kg (at the time of a prior inspection),
8. A person shall not have a schedule of consultation of another hospital until this administration study.
9. A person judged unfit of this study by responsible doctor

Male

Healthy adult subjects
Sample collection for evaluating analysis and sampling methods in antidoping

An oral dose of 15 mg （three Migsis® Tablet 5mg） is administered orally to the each subject as a test drug, and urine and blood are collected from the test subjects.

Effects of sample collection method: Sample collection time, type and amount of sample collected

Detectable period of unchanged and metabolites of test drugs: Sample collection time, type and amount of sample collected

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