CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 122 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/NCT03801148
NCT03801148Phase 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 Following a High-Fat Meal

Takeda·interventional·Posted Jan 11, 2019·Updated Mar 19, 2020

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 122 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 11, 2019
Enrollment StartJan 10, 2019
Primary CompletionFeb 25, 2019
Study CompletionApr 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.5 years ago

Interventions

30 mg dexlansoprazole capsules manufactured at TOBdrug

Dexlansoprazole delayed-release capsules.

30 mg dexlansoprazole capsules manufactured at TPCdrug

Dexlansoprazole delayed-release capsules.

60 mg dexlansoprazole capsules manufactured at TOBdrug

Dexlansoprazole delayed-release capsules.

60 mg dexlansoprazole capsules manufactured at TPCdrug

Dexlansoprazole delayed-release capsules.