Pharmacokinetic Evaluation of MDZ028 (NCT03639428) | Clinical Trial Compass
CompletedNot Applicable
Pharmacokinetic Evaluation of MDZ028
37 participantsStarted 2011-06-23
Plain-language 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.
Who can participate
Age range
6 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (HI…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetic analysis of the oral solution of midazolam (ADV6209)