Study assessments.
ADVERSE EVENTS
Study assessments included complete physical examinations, vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, and oral temperature), 12-lead ECG, clinical laboratory tests (e.g., hematology, biochemistry, coagulation, and urinalysis), and monitoring for adverse events (AEs). Whole blood samples were collected to determine TBP concentrations at the following time points: pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 h post dose. Whole blood samples were assayed for TBP using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method (Charles River Laboratories) (