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COMPLETED
NCT03639428

Pharmacokinetic Evaluation of MDZ028

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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.

Official title: Pharmacokinetic Evaluation of MDZ028 After Single Administration of a New Oral Form, at the Time of Anesthetic Premedication in Children.

Key Details

Gender

All

Age Range

6 Months - 18 Years

Study Type

OBSERVATIONAL

Enrollment

37

Start Date

2011-06-23

Completion Date

2017-11-30

Last Updated

2026-06-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

Midazolam

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