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Physiological Study of the Human CYP3A Activity (PiSA)

NCT03204578 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-04-18

No results posted yet for this study

Summary

Investigator-initiated physiological study to characterize the function of a major drug metabolizing enzyme using a microdosed phenotyping probe to avoid unwanted, concentration-dependent effects.

Conditions

  • Cytochrome P450 CYP3A Enzyme Deficiency

Interventions

DRUG

AB (Midazolam OD formulation/Dormicum)

Oral disintegrating formulation (Midazolam OD Formulation). The Midazolam OD Formulation was developed by Kyukyu Pharmaceutical Co., Ltd

DRUG

BA (Dormicum/Midazolam OD formulation)

Oral disintegrating film (Midazolam OD Formulation). The Midazolam OD Formulation was developed by Kyukyu Pharmaceutical Co., Ltd

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Stephan Krähenbühl · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2017-09-25
Completion
2017-09-25

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204578 on ClinicalTrials.gov