CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 116 enrolled
Drug / intervention
30 mg dexlansoprazole capsules manufactured at TOB +3 moredrug
Likely dose
30 mg dexlansoprazole capsules manufactured at TOBfrom 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.

Search/NCT03131895
NCT03131895Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda GmbH Plant Oranienburg Relative to Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda Pharmaceutical Company Limited Osaka Plant

Takeda·interventional·Posted Apr 27, 2017·Updated Jun 14, 2019

In Brief

A Phase 1 clinical trial evaluating 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, and 2 other interventions for Healthy Volunteers. Completed, enrolled 116 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30 milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule manufactured at Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 27, 2017
Enrollment StartApr 25, 2017
Primary CompletionJul 3, 2017
Study CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago

Interventions

30 mg dexlansoprazole capsules manufactured at TOBdrug

Dexlansoprazole delayed-release.

30 mg dexlansoprazole capsules manufactured at TPCdrug

Dexlansoprazole delayed-release.

60 mg dexlansoprazole capsules manufactured at TOBdrug

Dexlansoprazole delayed-release.

60 mg dexlansoprazole capsules manufactured at TPCdrug

Dexlansoprazole delayed-release.