At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
Dexlansoprazole Delayed Release Orally Disintegrating Tablets +1 moredrug
Likely dose
Not stated in 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.
A Phase 1, Randomized, Open-Label, Single Center, Multiple-Dose, Two-Period, Crossover Study to Assess the Bioavailability, Safety, and Pharmacodynamics of Two 30 mg Dexlansoprazole Delayed-Release Orally Disintegrating Tablets Administered on the Tongue Relative to Oral Administration of One 60 mg Dexlansoprazole Delayed-Release Capsule in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Dexlansoprazole Delayed Release Orally Disintegrating Tablets and Dexlansoprazole Delayed Release Capsules for Bioavailability. Completed, enrolled 52 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioavailability
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedFeb 2014
Primary CompletionMar 2014
Study CompletionApr 2014
TodayJul 2026
First PostedFeb 17, 2014
Enrollment StartFeb 1, 2014
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.4 years ago
Interventions
Dexlansoprazole Delayed Release Orally Disintegrating Tabletsdrug
Dexlansoprazole delayed-release, orally disintegrating (OD) tablets
Dexlansoprazole Delayed Release Capsulesdrug
Dexlansoprazole delayed-release capsules