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.
This study was designed to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation (dry syrup, granules) and a single oral dose of TAK-536 commercial tablet by using open-label, 2 × 2 crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Unnamed facility
Kagoshima, Japan
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Time frame: Baseline up to Day 6 of Intervention Period 2
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
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Time frame: Baseline up to Day 6 of Intervention Period 2