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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
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.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 52 |
| Start date | 2015-03 |
| Completion | 2015-05 |
Conditions
- Japanese Healthy Adult Males
Interventions
- TAK-536 Tablet
- TAK-536 Dry Syrup Formulation
- TAK-536 Ganule Formulation
Primary outcomes
- AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort — Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
- Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort — Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
- AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort — Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
- Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort — Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Countries
Japan