At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 276 enrolled
Drug / intervention
TAK-438ASA +2 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, Crossover Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-438ASA Tablet and Single Oral Dose of TAK-438 Tablet Plus Aspirin Enteric-Coated Tablet (Study 1) and the Food Effect of Single Oral Dose of TAK-438ASA Tablet (Study 2) in Healthy Adult Male Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-438ASA, TAK-438, and 1 other intervention for Healthy Volunteers. Completed, enrolled 276 participants across 1 site.
Detailed Summary
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the effects of food on the pharmacokinetics of TAK-438ASA tablet in Japanese healthy adult men (Study 2).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartMar 2018
Primary CompletionOct 2018
Study CompletionOct 2018
TodayJul 2026
First PostedMar 7, 2018
Enrollment StartMar 8, 2018
Primary CompletionOct 10, 2018
Study CompletionOct 12, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.3 years ago
Interventions
TAK-438ASAdrug
TAK-438ASA tablet.
TAK-438drug
TAK-438 tablet.
Aspirindrug
Aspirin enteric-coated tablet.