Good clinical practice The sponsor provided a statement that all studies were conducted in accordance with the principles of Good Clinical Practice. Pharmacokinetics Studies providing pharmacokinetic data Table 10 below, shows the studies relating to each pharmacokinetic topic and the location of each study summary. Table 10. Submitted pharmacokinetic studies. PK topic Subtopic Study ID * PK in healthy General PK - Single dose IKP/ID33 * adults 109HV101 109HV102 * - Multi-dose FG-PK-03/04 * Bioequivalence† n/a Food effect FG-PK-02/02 * C-1903 * PK in special Target population § - Single dose 109MS101 * populations - Multi-dose n/a Hepatic impairment n/a Renal impairment n/a n/a Elderly n/a Males versus females n/a PK PK Aspirin (ASA) 109HV106 * interactions Avonex (Interferon 109HV103 * β-1a) Copaxone (glatiramer acetate) 109HV104 * Healthy subjects n/a
Good clinical practice The sponsor provided a statement that all studies were conducted in accordance with the principles of Good Clinical Practice. Pharmacokinetics Studies providing pharmacokinetic data Table 10 below, shows the studies relating to each pharmacokinetic topic and the location of each study summary. Table 10. Submitted pharmacokinetic studies. PK topic Subtopic Study ID * PK in healthy adults General PK - Single dose IKP/ID33 * 109HV101 109HV102 * - Multi-dose FG-PK-03/04 * Bioequivalence† n/a Food effect FG-PK-02/02 * C-1903 * PK in special populations Target population § - Single dose 109MS101 * - Multi-dose n/a Hepatic impairment n/a Renal impairment n/a n/a Elderly n/a PK Males versus females n/a PK interactions Aspirin (ASA) 109HV106 * Avonex (Interferon β-1a) 109HV103 * Copaxone (glatiramer acetate) 109HV104 * Healthy subjects n/a
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