The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.
Bioequivalence of 2 SYR-472 25 mg tablets and 1 SYR-472 50 mg tablet administered to healthy adult males will be investigated in a randomized, open-label, crossover study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SYR-472 25mg, 50mg
Unnamed facility
Fukuoka, Japan
AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Cmax: Maximum Observed Plasma Concentration for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Tmax: Time to Reach the Cmax for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)
Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29).
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
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Number of Participants With TEAEs Related to Vital Signs
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Related to Body Weight
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
Time frame: Baseline up to 7 days after the last dose of study drug (Day 8) in each period