At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 60 enrolled
Drug / intervention
ADASUVE 10 mg 2 doses 2 hours apart +3 moredrug
Likely dose
ADASUVE 10 mg 2 doses 2 hours apartfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Thorough QT/QTc Study of 2 Doses of ADASUVE® in Healthy Volunteers
In Brief
A Phase 4 clinical trial evaluating ADASUVE 10 mg 2 doses 2 hours apart, Inhaled Placebo, and 2 other interventions for Healthy Volunteers. Completed, enrolled 60 participants across 1 site.
Detailed Summary
Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesNetherlands
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionJul 2013
TodayJul 2026
First PostedMay 15, 2013
Enrollment StartMay 1, 2013
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.1 years ago
Interventions
ADASUVE 10 mg 2 doses 2 hours apartdrug
Inhaled loxapine 10 mg 2 doses 2 hours apart
Inhaled Placebodrug
Staccato placebo via inhalation x 2 at 2 hours apart
Oral moxifloxacin 400 mgdrug
Oral moxifloxacin 400 mg single dose
Oral placebodrug
Oral capsule identical in appearance to moxifloxacin