CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
TAK-438 OD +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.

Search/NCT03808493
NCT03808493Phase 1Completed
CompareCT.gov

A Randomized, Open-Label, Single-Dose, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of TAK-438 OD (Orally Disintegrating) 20 mg Tablet When Administered Without Water (Study 1) or With Water (Study 2) and TAK-438 20 mg Tablet When Administered With Water in Japanese Healthy Volunteer Male Subjects

Takeda·interventional·Posted Jan 17, 2019·Updated Apr 7, 2020

In Brief

A Phase 1 clinical trial evaluating TAK-438 OD and TAK-438 for Japanese Healthy Adult Male. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2) in Japanese healthy adult male participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Healthy Adult Male
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 17, 2019
Enrollment StartJan 30, 2019
Primary CompletionMar 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.5 years ago

Interventions

TAK-438 ODdrug

TAK-438 OD tablet

TAK-438drug

TAK-438 tablet