Midazolam Clinical Trial
Official title:
Pharmacokinetic Evaluation of MDZ028 After Single Administration of a New Oral Form, at the Time of Anesthetic Premedication in Children.
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.
In the absence of a licensed formulation in many countries worldwide, ADV6209, an innovative
2mg/ml oral solution of midazolam containing cyclodextrin, has been developed for moderate
sedation in paediatric patients. Population pharmacokinetics for ADV6209 is reported.
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. Plasma concentrations of midazolam were
discribed by a two-compartement model. An additional one-compartement model was added for a
α-hydroxymidazolam.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01256866 -
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
|
Phase 4 | |
| Recruiting |
NCT05192629 -
Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging
|
Phase 3 | |
| Recruiting |
NCT04729478 -
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
|
N/A | |
| Not yet recruiting |
NCT06275594 -
Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
|
Phase 2 | |
| Completed |
NCT05942365 -
A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
|
Phase 1 | |
| Completed |
NCT04068948 -
Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
|
Phase 4 | |
| Not yet recruiting |
NCT06407518 -
Preoperative Oral Midazolam to Postoperative Pain Relief in Sleep Disturbance or Anxiety Patients With Colorectal Cancer
|
N/A | |
| Completed |
NCT04718259 -
The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
|
Early Phase 1 | |
| Completed |
NCT03397069 -
Midazolam Additive to Local Anesthetic in Peribulbar Block
|
N/A | |
| Completed |
NCT03030911 -
Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients
|
Phase 4 | |
| Completed |
NCT05371600 -
Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption
|
Phase 4 | |
| Completed |
NCT04652661 -
Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics
|
Phase 4 | |
| Not yet recruiting |
NCT06018207 -
ED50 of Midazolam Oral Solution for Preoperative Hypnosis in Adults : An Up-and-Down Sequential Allocation Trial
|
N/A | |
| Recruiting |
NCT05485519 -
Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.
|
Phase 3 | |
| Completed |
NCT04602845 -
Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients
|
Phase 4 | |
| Completed |
NCT04656964 -
Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy
|
N/A |