At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
TAK-536 +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 Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Healthy Adult Male Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-536 for Japanese Healthy Adult Male Participants. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Healthy Adult Male Participants
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartFeb 2017
Primary CompletionMar 2017
TodayJul 2026
First PostedFeb 3, 2017
Enrollment StartFeb 10, 2017
Primary CompletionMar 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.4 years ago
Interventions
TAK-536drug
TAK-536 granules.
TAK-536drug
TAK-536 tablet.