Turku University Hospital
Turku, 20520, Finland
NCT Number: NCT00837187
In a recent study by Yuen et al it was shown that preoperative intranasal administration of dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no information on the pharmacokinetics of dexmedetomidine after intranasal administration.
The aim of this study is to investigate the comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of intranasally administered dexmedetomidine will be calculated. In addition, we will report the effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of intranasally administered dexmedetomidine.
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Phase 1
Turku, 20520, Finland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 ug
100 ug
Time frame: At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h.
Time frame: At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 5 and 10 h. Only local nasal tolerability is assessed at 5 and 10 h.
University of Turku
Other
Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects
Acronym: INDEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07676955
Cesarean Birth, Sedation
Istanbul, Sultangazi, Turkey (Türkiye)
View Trial DetailsNCT06538883
Mechanical Ventilation, Sedation
Nanjing, Jiangsu, China
View Trial DetailsNCT07580768
Dexmedetomidine, Double-J Ureteral Stent
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT05559970
ICU, Lung Diseases
Bangkok Noi, Bangkok, Thailand
View Trial Details