At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
Sufentanil NanoTab (SUF NT) 15 mcg +1 moredrug
Likely dose
Sufentanil NanoTab (SUF NT) 15 mcgfrom 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.
IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Sufentanil NanoTab (SUF NT) 15 mcg and Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg for Pharmacokinetics. Completed, enrolled 19 participants across 1 site.
Detailed Summary
Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedNov 5, 2012
Enrollment StartNov 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.7 years ago
Interventions
Sufentanil NanoTab (SUF NT) 15 mcgdrug
Period 1: One dose of SUF NT 15 mcg administered sublingually
Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcgdrug
Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day