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Pharmacokinetic Evaluation of MDZ028

NCT03639428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2018-08-21

No results posted yet for this study

Summary

Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling.

Conditions

  • Midazolam

Interventions

DRUG

Midazolam

All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Hervé Dupont, MD, PhD · CHU AMIENS

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-23
Primary Completion
2017-11-30
Completion
2017-11-30

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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 NCT03639428 on ClinicalTrials.gov