At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
TAK-536 Tablet +2 moredrug
Likely dose
TAK-536 Tablet 10 mgfrom 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, 2×2 Crossover, Phase I Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-536 Pediatric Formulations and TAK-536 Commercial Tablet in Healthy Adult Male Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-536 Tablet, TAK-536 Dry Syrup Formulation, and 1 other intervention for Japanese Healthy Adult Males. Completed, enrolled 52 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Healthy Adult Males
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMar 2015
Primary CompletionMay 2015
TodayJul 2026
First PostedMar 27, 2015
Enrollment StartMar 1, 2015
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.3 years ago
Interventions
TAK-536 Tabletdrug
TAK-536 10 mg tablet
TAK-536 Dry Syrup Formulationdrug
TAK-536 dry syrup formulation
TAK-536 Ganule Formulationdrug
TAK-536 granule formulation