The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole tablets in Chinese participants at high risk for invasive fungal infections. Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
65
Posaconazole 300 mg solid oral tablet
Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8
The ssCavg was calculated in order to determine the percentage of participants achieving the pharmacokinetic (PK) target of ssCavg \>500 ng/mL on Day 8 when plasma drug levels had reached steady state.
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of Posaconazole on Day 8
The ssAUC0-24hr was calculated to determine the mean plasma drug concentration in the Intensive and Sparse PK subgroup from immediately after dosing to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation \[CV\]), where CV is calculated as (100 x standard deviation/arithmetic mean).
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
Steady-state Maximum Concentration (ssCmax) of Posaconazole on Day 8
The ssCmax was calculated in order to determine the maximum post-dose plasma drug concentration in the Intensive and Sparse PK subgroup on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation \[CV\]), where CV is calculated as (100 x standard deviation/arithmetic mean).
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
Steady-state Minimum Concentration (ssCmin) of Posaconazole on Day 8
The ssCmin was calculated in order to determine the lowest measurable drug concentration in the Intensive and Sparse PK subgroup up to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation \[CV\]), where CV is calculated as (100 x standard deviation/arithmetic mean).
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
Time to Steady-state Maximum Concentration (ssTmax) of Posaconazole on Day 8
The ssTmax was calculated in order to determine the amount of time required to reach ssCmax in the Intensive and Sparse PK subgroup on Day 8.
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Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
AUC0-24hr of Posaconazole on Day 1
The AUC0-24hr was calculated to determine the mean plasma drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation \[CV\]), where CV is calculated as (100 x standard deviation/arithmetic mean).
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
Cmax of Posaconazole on Day 1
The Cmax was calculated to determine the maximum plasma drug concentration up to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation \[CV\]), where CV is calculated as (100 x standard deviation/arithmetic mean).
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
Cmin of Posaconazole on Day 1
The Cmin was calculated in order to determine the lowest measurable drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation \[CV\]), where CV is calculated as (100 x standard deviation/arithmetic mean).
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
Tmax of Posaconazole on Day 1
The Tmax was calculated in order to determine the time required to reach Cmax in the Immediate and Sparse PK subgroup on Day 1.
Time frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1