Investigation of correlation between pharmacokinetics of midazolam and DNA methylation in hepatic derived cells to predict CYP3A4 activity

Not Applicable

• Conditions: healthy male and female

• Registration Number: JPRN-UMIN000017842
• Lead Sponsor: Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

The investigators must ensure that all subjects being considered meet the following exclusion criteria or conditions: 1) history of allergy to any drugs 2) medical attention within 2 months prior to participation 3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4) donation of 400 mL or more of blood within 12 weeks prior to participation 5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity 6) history of drug abuse 7) alcohol abuse 8) taking drugs or healthy foods which may affect drug metabolism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified