Pharmacokinetics Studies providing pharmacokinetic data Table 1 (below) shows the studies relating to each pharmacokinetic topic. 1. Submitted pharmacokinetic studies. PK topic Subtopic Study ID PK in healthy General PK - Single dose M/34273/ 05 adults 00 M/34273/ 03 04 M/34273/ 01 - Multi-dose LAS-PK-12A M/34273/ 06 Bioequivalence† - Single dose Not applicable - Multi-dose Food effect Not applicable PK in special Target population §- Single dose M/34273/ 21 populations - Multiple dose M/34273/ 09 Hepatic impairment None impairment M/34273/08 None Elderly None Males versus females None related PK PK interactions Not evaluated None Population PK Healthy subjects None analyses Target population None None Bioequivalence of different formulations. † § Subjects who would be eligible to receive the drug if approved for the proposed indication.
Pharmacokinetics Studies providing pharmacokinetic data Table 1 (below) shows the studies relating to each pharmacokinetic topic. 1. Submitted pharmacokinetic studies. PK topic Subtopic Study ID PK in healthy adults General PK - Single dose M/34273/ 05 00 M/34273/ 03 04 M/34273/ 01 - Multi-dose LAS-PK-12A M/34273/ 06 Bioequivalence† - Single dose Not applicable - Multi-dose Food effect Not applicable PK in special populations Target population §- Single dose - Multiple dose M/34273/ 21 M/34273/ 09 Hepatic impairment None impairment M/34273/08 None Elderly None PK Males versus females None PK interactions Not evaluated None Population PK analyses Healthy subjects None Target population None None † Bioequivalence of different formulations. § Subjects who would be eligible to receive the drug if approved for the proposed indication. related
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