A verification study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: Midazolam single oral administration Midazolam single oral administration after 6 days Anchu‐san (7.5g/day) dose CONDITION: Japanese healthy male PRIMARY OUTCOME: The pharmacokinetic parameters of midazolam in serum (AUC 0‐10, Cmax, t1/2, tmax). SECONDARY OUTCOME: The sedative action after midazolam oral administration: VAS; Safety assessment (pulse oximeter, vital measurement, adverse event) INCLUSION CRITERIA: 1) Age: 20 ‐ 45 years old at the time of informed consent 2)Sex: male 3) Subjects are competent to consent, keep the rules of the study and are able to report self condition. 4) Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Epistemonikos ID: fb756ba0c3124a41be7fbe84b82a3464c8a7c125
First added on: Aug 22, 2024