臨床研究等提出・公開システム

A Phase II Study to Evaluate the Pharmacokinetics and Safety of MR19A13A in Pediatric Patients.

A Phase II Study of MR19A13A.

Nobuyo Oya

Maruishi Pharmaceutical Co., Ltd.

2-2-18,Imazu-Naka, Turumi-ku Osaka

nobuyo_oya@maruishi-pharm.co.jp

Clinical Study Unit

Maruishi Pharmaceutical Co., Ltd.

2-2-18,Imazu-Naka, Turumi-ku Osaka

+81-669620318

kazuyo_ito@maruishi-pharm.co.jp

Complete

Oct. 27, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

1) Japanese Patients aged from 6 months to 16 years, at the time of informed consent.
2) Patients with written consent from their legal representatives; If the patient is over 7 years, it is desirable to obtain the assent also from the patient as possible.

1) Patients with the history of hypersensitivity or suspected hypersensitivity to any ingredients of the study drug.
2) Patients with acute angle-closure glaucoma.
3) Patients with myasthenia gravis.
4) Patients receiving the drug containing HIV protease inhibitors, efavirenz, or cobicistat.
5) Patients receiving St. John's wort supplement and are unable to discontinue taking the supplement from 1 week prior to the start of study drug administration up to 8 hours after the completion of study drug administration.
6) Patients with shock, coma, or acute alcohol intoxication with suppressed vital signs.
7) Patients with severe hepatic, renal, cardiovascular, gastrointestinal, or hematological disorders.
8) Patients using or expected to use artificial heart-lungs during the surgery.
9) Patients expected to receive blood transfusion during or after the surgery (up to 8 hours after completion of the study drug administration)
10) Patients with airway problems, such as upper airway stenosis including tonsillar hypertrophy, difficult airways, etc.
11) Patients with respiratory function disorder, such as lung disease, scoliosis, etc.

Both

Patients undergoing a scheduled surgery under general anesthesia.

MR19A13A is administered orally in one swallowing motion as possible.

Pharmacokinetics
1) Plasma concentration and Pharmacokinetic parameters of unchanged MR19A13A and its metabolites.

Safety
1) Adverse events and adverse reaction
2) Laboratory tests
3) Vital signs
systolic blood pressure, diastolic blood pressure, pulse rate
4) SpO2, respiratory rate
5) electrocardiogram

+81-742-46-6001

Oct. 06, 2022

No

none