Pharmacokinetic Evaluation of MDZ028

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.

Inclusion Criteria: * Child (boy or girl) for whom surgery under general anesthesia is scheduled. * Child aged 6 months to 17 years old. * Child with a body mass index between the 3rd and 97th percentile. * Child with ASA (American Society of Anesthesiology) status of I or II. Young girl of childbearing age (ie after puberty) and sexually active to have a result negative to the pregnancy test. * Child whose parents / legal representative (s) agree to sign a consent form. * Child whose opinion / agreement was / tried to be collected. * Child and parents / legal representative (s) being ready and able to participate in the study, understanding and undertaking to respect the study procedures throughout the duration of the study. * Child enrolled in a social security scheme. Exclusion Criteria: * Child with midazolam allergy, benzodiazepine hypersensitivity or hypersensitivity known to one of the excipients of the formulation of the study. * Child with respiratory disease (severe respiratory failure, acute respiratory depression). * Child with heart disease. * Child with gastrointestinal disorders that may affect absorption or gastroesophageal reflux. * Child with growth disorders or abnormal weight-of-weight. * Child taking Cytochrome P450 Interactions Within 60 Days of Inclusion in the study. * Child with kidney failure, liver failure, history of myasthenia gravis, or neurological disease. * Pregnant or lactating girl. * Child who has a known human immunodeficiency virus (HIV) infection, or active hepatitis B, or active hepatitis C. * A child who could present any condition that may prevent his participation in the study, according to the judgment of the investigator.