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Clinical pharmacokinetic study of MD-352 in healthy postmenopausal female subjects

Clinical pharmacokinetic study of MD-352 in healthy postmenopausal female subjects

Mori Takuya

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

clinical.trials.contact@mochida.co.jp

Public relations

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

+81-3-3225-6303

webmaster@mochida.co.jp

Not Recruiting

May. 14, 2025

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

other

-Subjects with a BMI of at least 18.5 kg/m2 and less than 25.0 kg/m2 and a body weight of at least 45 kg and less than 65 kg at screening
-Postmenopausal women who have been without menstruation for 12 or more months without accompanying medical reasons

-Subjects deemed unsuitable by the principal investigator or sub-investigator
-Subjects with drug hypersensitivity
-Subjects who have used drugs and supplements within 7 days prior to administration of the investigational drug
-Subjects with a positive result in urine drug or alcohol test
-Smokers or subject with a positive result in smoking test
-Subjects who have not passed 16 weeks since participation in another clinical trial

Female

healthy postmenopausal female subjects

-Single oral dose of MD-352 Dose A or MD-352 Dose B
-Simultaneous single oral dose of Rosuvastatin and MD-352 after single oral dose of Rosuvastatin
-Repeated oral administration of MD-352 for 7 days after single oral dose of Midazolam, followed by simultaneous oral administration of Midazolam and MD-352 at the final dose

-Pharmacokinetic parameters
-Adverse events

+81-42-625-5216

May. 12, 2025

No

none