PK in healthy Single dose (45 + 15 split dose) 156-07-262 adults Single dose (Korean subjects) 156-KOA-0801 * Bioequivalence† - Single dose 156-11-295 * Food effect 156-11-295 * PK in renal impairment 156-09-282 * PK in ADPKD General PK subjects -Single dose 156-04-248 * -Multiple dose 156-04-001 * -Multiple dose 156-04-249 * -Multiple dose (90 + 30 split dose) 156-09-285 Renal impairment 156-06-260 156-09-284 Population PK ADPKD subjects 156-11-296 * and PK/PD analyses * Indicates the primary aim of the study. Bioequivalence of different formulations. † None of trial pharmacokinetic studies had deficiencies that excluded their results from consideration. There were two studies listed in the table of contents for the submission as studies not previously evaluated by the TGA. However, both of these have in fact been previously reviewed by the TGA and are therefore not reviewed in this report. These studies are listed in Table 3. Table 3: Pharmacokinetic studies not evaluated Study ID Subtopic(s) 156-96-205 Interactions with frusemide and hydrochlorothiazide 156-01-224 Population PK analysis in subjects with hyponatraemia or failure. Summary of pharmacokinetics The following is a summary of the new PK data contained in the submission. The information in the summary is derived from conventional pharmacokinetic studies unless otherwise stated.
PK in healthy adults Single dose (45 + 15 split dose) 156-07-262 Single dose (Korean subjects) 156-KOA-0801 * Bioequivalence† - Single dose 156-11-295 * Food effect 156-11-295 * PK in renal impairment 156-09-282 * PK in ADPKD subjects General PK -Single dose 156-04-248 * -Multiple dose 156-04-001 * -Multiple dose 156-04-249 * -Multiple dose (90 + 30 split dose) 156-09-285 Renal impairment 156-06-260 156-09-284 Population PK and PK/PD analyses ADPKD subjects 156-11-296 * * Indicates the primary aim of the study. † Bioequivalence of different formulations. None of pharmacokinetic studies had deficiencies that excluded their results from consideration. There were two studies listed in the table of contents for the submission as studies not previously evaluated by the TGA. However, both of these have in fact been previously reviewed by the TGA and are therefore not reviewed in this report. These studies are listed in Table 3. Table 3: Pharmacokinetic studies not evaluated Study ID Subtopic(s) 156-96-205 Interactions with frusemide and hydrochlorothiazide 156-01-224 Population PK analysis in subjects with hyponatraemia or failure. Summary of pharmacokinetics The following is a summary of the new PK data contained in the submission. The information in the summary is derived from conventional pharmacokinetic studies unless otherwise stated. trial
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