At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 26 enrolled
Drug / intervention
Transderm Scop® +1 moredrug
Likely dose
Transderm Scop® 1.5 mgfrom 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.
Absolute Bioavailability/Pharmacokinetic and Residual Drug Analysis of the Transderm Scōp System in Healthy Adults
In Brief
A Phase 4 clinical trial evaluating Transderm Scop® and Intravenous scopolamine hydrobromide for Healthy. Completed, enrolled 26 participants across 1 site.
Detailed Summary
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsUniversity of Minnesota
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedJan 2017
Primary CompletionApr 2017
Study CompletionMar 2018
TodayJul 2026
First PostedJan 24, 2017
Enrollment StartNov 1, 2016
Primary CompletionApr 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.4 years ago
Interventions
Transderm Scop®drug
TDDS dosage is 1.5 mg/72 hrs
Intravenous scopolamine hydrobromidedrug
0.4 mg via intravenous injection