臨床研究等提出・公開システム

Administration study of preparation containing the Doping Prohibited Substances to healthy adult males

Administration study of preparation containing the Doping Prohibited Substances to healthy adult males

21

healthy adult males

There were no adverse events.

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.

Subjects received a single oral dose of one of the study drugs, Bastarel F Tablets 3 mg, Sosegon Tablets 25 mg, or Tramal OD Tablets 25 mg, and urine and blood samples for quantitative analysis of unchanged drug and metabolites of the study drugs were collected from the subjects from the morning following their admission until 84 hours after administration of the study drugs, according to the study protocol. Urine and blood samples were collected from the test subjects.

No

-

https://www.clinicaltrials.jp/file/AfcwIbked

Ikushima Ippei

Souseikai Sumida Hospital

1-29-1, Honjo, Sumida-ku, Tokyo 130-0004, Japan

ippei-ikushima@lta-med.com

Sato Mitsuhito

LSI Medience Corporation

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

+81-3-5994-2351

satou.mitsuhiko@ma.medience.co.jp

completed

Sept. 14, 2018

Interventional

After preliminary examinations (medical history, current medical history, and safety confirmation items) are conducted on Japanese healthy adult male subjects within 30 days prior to administration of the study drug, 21 of them will be administered the study drug under open-label conditions, and urine and blood samples will be collected from the subjects from the morning following admission until 84 hours after administration of the study drug, in accordance with the study protocol. Upon administration of the study drug and collection of samples, tests and observations will be performed to confirm safety. Each sample will be stored and maintained in a prescribed manner before being subjected to quantitative analysis of unchanged drug and metabolites of the test drug.

other

N/A

1) BMI more than 18.5 and less than 25.0
2) Person who were judged to be appropriate to participate in this study by the principal investigator or the Sub-investigator.

1) Those who have had allergic symptoms due to drugs
2) Alcohol or drug addicts (including past history)
3) Within 2 weeks of the administration of the study drug, those who used medicinal products, over-the-counter drugs and those who consumed supplements, foods containing St. John's wort, grapefruit, or their processed products
4) A person who may be treated for any disease or during the study period
5) Those who received the study drug or study drug within 16 weeks of the study drug administration, and also study drug administration, or those who received the study drug containing the approved ingredients within 12 weeks of the day
6) Person who received blood collection under the following conditions for blood donation etc.
200 mL or more within 4 weeks of administration, 400 mL or more within 12 weeks of administration(In the case of the component blood donation, within 14 days of the administration day regardless of the blood collection volume)
7) Person who weighs less than 50 kg (at the time of prior examination)
8) Those who have a history of heart disease, liver disease, kidney disease, or who have high blood pressure, depression, mania, other psychiatric disorders, epilepsy, sleep related disease or history
9) Persons who were considered by the Study Investigator or Investigator as inappropriate for this study

Male

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

Any one of the study drug Bastarel F tablet 3 mg, Sosegon tablet 25 mg and Tramal OD tablet 25 mg is administered orally as a single dose to the subject after breakfast, and urine and blood samples are collected from the 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

+81-92 283-7701

Sept. 14, 2018