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Clinical Trials/JPRN-jRCT2071230023
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

Sponsor
Takeuchi Yutaka

Identifiers

Registry ID
JPRN-jRCT2071230023

Dates

Last updated
(2 years ago)

Regulatory & Sharing

Has Results
No

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