Phoenix Winnonlin9/21/2020
PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3. Part 1: Elimination Rate Constant (Kel) of Daprodustat Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2 Blood samples were collected at indicated timepoints and PK analysis was performed.Listing a study does not mean it has been evaluated by the U.S.Federal Government.
Part 1 is the bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. In this part, subjects will receive single dose of 4 mg daprodustat tablet in fasting and fed state in a crossover manner. There will 5-day wash-out period between each intervention period. There will be approximately 52 subjects in Part 1 and 12 subjects in Part 2. There will be a wash-out period of 5 days between the Periods. A single dose of 2 tablets of 2 mg daprodustat will be administered in a fasted state during Part 1 of the study. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3. PK population comprised of all participants in the Safety population (all randomized participants) who received at least one dose of study intervention) who had at least 1 non-missing PK assessment. Part 1:Maximum Observed Drug Concentration (Cmax) of Daprodustat Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2 Blood samples were collected at indicated timepoints and pharmacokinetic (PK) analysis was performed. Part 1:Terminal Phase Half-life (T12) of Daprodustat and Mean Residence Time (MRT) Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2 Blood samples were collected at indicated timepoints and PK analysis was performed. Part 1: Time of Occurrence of Cmax (Tmax) of Daprodustat Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2 Blood samples were collected at indicated timepoints and PK analysis was performed. Part 1:Apparent Clearance (CLF) of Daprodustat Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2 Blood samples were collected at indicated timepoints and PK analysis was performed. Part 1:Apparent Oral Volume of Distribution (VzF) of Daprodustat Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2 Blood samples were collected at indicated timepoints and PK analysis was performed. Part 1: Elimination Rate Constant (Kel) of Daprodustat Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2 Blood samples were collected at indicated timepoints and PK analysis was performed.
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