JPRN-jRCT2071230023CompletedPhase 1
Drug-Drug interaction study of AJM300(1)- Combination clinical pharmacology study of oral midazolam, oral prednisolone, oral atorvastatin and intravenous midazolam in healthy male subjects
Takeuchi Yutaka0 sitesEnrollment: 88Started: June 19, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 88
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to < 46age old (—)
- Sex
- Male
Inclusion Criteria
- A Japanese healthy male adult aged from 20 to less than 46 inclusive at the time of written informed consent
- A BMI meeting the following criterion at screening: Japanese subjects, >= 18.5 and < 25.0 kg/m2
- Judging by the investigator or sub-investigator to have no significant clinically relevant abnormalities in examination findings, physiological tests, and laboratory tests, and who have no problem participating in this study
- Consenting in writing to participate in this clinical study on his own free will and able to comply with the requirements in the clinical study
Exclusion Criteria
- History or complication at screening or any physical finding, vital sign, ECG finding, or laboratory value at screening or baseline that raises suspicion of a clinically abnormal symptom or organ dysfunction that requires treatment
- Subjects who are contraindicated to administer the concomitant drug according to the current label of the drug.
- Subjects who have a white blood cell count of 4000/uL or less at screening and on the day of hospitalization (sequence 1 to 4: day -2, sequence 5: day -1)
- Subjects who took grapefruit, grapefruit juice and foods containing these ingredients within 8 days before the start of the clinical trial and St. John's wort and their ingredients within 15 days before the start of the clinical trial.
- Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator
Investigators
Identifiers
- Registry ID
- JPRN-jRCT2071230023
Dates
- Last updated
- (2 years ago)
Regulatory & Sharing
- Has Results
- No
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