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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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031250069
Enrollment
64
Registered
2025-04-28
Start date
2025-05-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy postmenopausal female subjects

Interventions

-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

Sponsors

Mori Takuya
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

MeasureTime frame
-Pharmacokinetic parameters -Adverse events

Contacts

Public ContactPublic relations

Mochida Pharmaceutical Co., Ltd.

webmaster@mochida.co.jp+81-3-3225-6303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026