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This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A: Oseltamivir with HD | Experimental | Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir. |
|
| Regimen B: Oseltamivir with CAPD | Experimental | Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL). | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose |
| Cmax of Oseltamivir in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose |
| Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose |
| Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose |
| Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL). |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Oseltamivir by Timepoint in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch | 8011 | New Zealand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oseltamivir With HD | Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period. |
| FG001 | Oseltamivir With CAPD | Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All Enrolled: All participants enrolled into the study regardless of treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oseltamivir With HD | Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period. |
| BG001 | Oseltamivir With CAPD |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL). | Pharmacokinetic (PK) Analysis Population (First Dose Subpopulation): All participants who completed treatment and provided evaluable data during the first dose assessment period. | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose |
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From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oseltamivir With HD | Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting not otherwise specified | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose |
| AUC of Oseltamivir in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose |
| AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose |
| AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose |
| Cmax of Oseltamivir in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
| Cmax of Oseltamivir in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose |
| Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
| Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose |
| AUC of Oseltamivir in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
| AUC of Oseltamivir in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose |
| AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
| AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose |
| Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose |
| Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose |
| Tmax of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose |
| Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants | Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h). | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose |
| CL/F of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose |
| Renal Clearance (CLr) of Oseltamivir in HD Participants | Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose |
| CLr of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose |
| Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40 |
| Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants | Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | Urine samples 0 to 42 hours from D1 dose |
| Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants | Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | Urine samples 0 to 42 hours from D1 dose |
| Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants | Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40 |
| Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
| Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants | Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
| Tmax of Oseltamivir in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
| Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
| Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h). | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose |
| Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose |
| CL/F of Oseltamivir in CAPD Participants | Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose |
| CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose |
| CLr of Oseltamivir in CAPD Participants | Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose |
| CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose |
| CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h. | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose |
| Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants | Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | Urine samples 0 to 48 hours from D1 dose |
| Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants | Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | Urine samples 0 to 48 hours from D1 dose |
| Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants | Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | Dialysate samples 0 to 48 hours from D1 dose |
| Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants | Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | Dialysate samples 0 to 48 hours from D1 dose |
Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Cmax of Oseltamivir in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | PK Analysis Population (Second Dose Subpopulation): All participants who completed treatment and provided evaluable data during the second dose assessment period. | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose |
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| Primary | Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose |
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| Primary | Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | PK Analysis Population (Second Dose Subpopulation). | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose |
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| Primary | Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL). | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose |
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| Primary | AUC of Oseltamivir in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | PK Analysis Population (Second Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose |
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| Primary | AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose |
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| Primary | AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 | Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | PK Analysis Population (Second Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose |
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| Primary | Cmax of Oseltamivir in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
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| Primary | Cmax of Oseltamivir in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | PK Analysis Population (Second Dose Subpopulation). | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose |
|
|
|
| Primary | Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
|
|
|
| Primary | Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL. | PK Analysis Population (Second Dose Subpopulation). | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose |
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|
|
| Primary | AUC of Oseltamivir in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
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|
|
| Primary | AUC of Oseltamivir in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | PK Analysis Population (Second Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose |
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|
|
| Primary | AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose |
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|
|
| Primary | AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 | Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL. | PK Analysis Population (Second Dose Subpopulation). | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose |
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|
|
| Secondary | Plasma Concentration of Oseltamivir by Timepoint in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | PK Analysis Population; number (n) equals (=) number of participants included at specified timepoints in the analysis. | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose |
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|
|
| Secondary | Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | PK Analysis Population; n = number of participants included at specified timepoints in the analysis. | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose |
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|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | PK Analysis Population; n = number of participants included in the specific dose analysis. | Posted | Mean | Standard Deviation | hours | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose |
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|
|
| Secondary | Tmax of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | PK Analysis Population; n = number of participants included in the specific dose analysis. | Posted | Mean | Standard Deviation | hours | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose |
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| Secondary | Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants | Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h). | PK Analysis Population; n = number of participants included in the specific dose analysis. | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose |
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| Secondary | CL/F of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h. | PK Analysis Population; n = number of participants included in the specific dose analysis. | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose |
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| Secondary | Renal Clearance (CLr) of Oseltamivir in HD Participants | Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose |
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| Secondary | CLr of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose |
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| Secondary | Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants | Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h. | PK Analysis Population; n = number of participants included in the specific dose analysis. | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40 |
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| Secondary | Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants | Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | percentage of oseltamivir dose | Urine samples 0 to 42 hours from D1 dose |
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|
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| Secondary | Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants | Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | percentage of osteltamivir dose | Urine samples 0 to 42 hours from D1 dose |
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| Secondary | Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants | Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | PK Analysis Population. | Posted | Mean | Standard Deviation | ng/mL | Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40 |
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|
| Secondary | Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | PK Analysis Population. | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
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|
|
| Secondary | Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants | Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL. | PK Analysis Population. | Posted | Mean | Standard Deviation | ng/mL | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
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|
|
| Secondary | Tmax of Oseltamivir in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | PK Analysis Population. | Posted | Mean | Standard Deviation | hours | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
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|
|
| Secondary | Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours. | PK Analysis Population. | Posted | Mean | Standard Deviation | hours | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose |
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| Secondary | Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h). | PK Analysis Population. | Posted | Mean | Standard Deviation | 1/h | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose |
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|
|
| Secondary | Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours. | PK Analysis Population. | Posted | Mean | Standard Deviation | hours | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose |
|
|
|
| Secondary | CL/F of Oseltamivir in CAPD Participants | Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h. | PK Analysis Population. | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose |
|
|
|
| Secondary | CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h. | PK Analysis Population. | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose |
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|
|
| Secondary | CLr of Oseltamivir in CAPD Participants | Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose |
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|
| Secondary | CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose |
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| Secondary | CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants | Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | L/h | Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose |
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| Secondary | Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants | Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | percentage of oseltamivir dose | Urine samples 0 to 48 hours from D1 dose |
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| Secondary | Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants | Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | percentage of oseltamivir dose | Urine samples 0 to 48 hours from D1 dose |
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| Secondary | Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants | Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | percentage of oseltamivir dose | Dialysate samples 0 to 48 hours from D1 dose |
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| Secondary | Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants | Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered. | PK Analysis Population (First Dose Subpopulation). | Posted | Mean | Standard Deviation | percentage of oseltamivir dose | Dialysate samples 0 to 48 hours from D1 dose |
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|
| 1 |
| 12 |
| 8 |
| 12 |
| EG001 | Oseltamivir With CAPD | Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period. | 2 | 12 | 10 | 12 |
| Peritonitis | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Pericarditis not otherwise specified | Cardiac disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Diarrhoea not otherwise specified | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Dizziness (excluding vertigo) | General disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Haemorrhage not otherwise specified | General disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Pain in jaw | General disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Headache not otherwise specified | Nervous system disorders | MedDRA (4.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Appetite decreased | Metabolism and nutrition disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Calcification metastatic | Metabolism and nutrition disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Skin disorder not otherwise specified | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Tongue oedema | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Sore throat not otherwise specified | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Blood culture positive | Infections and infestations | MedDRA (4.0) | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (4.0) | Non-systematic Assessment |
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| Urinary tract infection not otherwise specified | Infections and infestations | MedDRA (4.0) | Non-systematic Assessment |
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| Vaginitis | Infections and infestations | MedDRA (4.0) | Non-systematic Assessment |
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| Vaginosis bacterial not otherwise specified | Infections and infestations | MedDRA (4.0) | Non-systematic Assessment |
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| Anaemia not otherwise specified | Blood and lymphatic system disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Anaemia not otherwise specified, aggravated | Blood and lymphatic system disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Hepatic function abnormal not otherwise specified | Hepatobiliary disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Skin injury not otherwise specified | Injury, poisoning and procedural complications | MedDRA (4.0) | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (4.0) | Non-systematic Assessment |
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| Depression not otherwise specified | Psychiatric disorders | MedDRA (4.0) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (4.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| 4 hours from D1 dose (n=12) |
|
| 8 hours from D1 dose (n=12) |
|
| 12 hours from D1 dose (n=12) |
|
| 20 hours from D1 dose (n=12) |
|
| 32 hours from D1 dose (n=12) |
|
| 42 hours from D1 dose (n=12) |
|
| 48 hours from D1 dose (n=12) |
|
| 49 hours from D1 dose (n=12) |
|
| 90 hours from D1 dose (n=12) |
|
| 0 hours from D38 dose (n=11) |
|
| 1 hour from D38 dose (n=11) |
|
| 2 hours from D38 dose (n=11) |
|
| 4 hours from D38 dose (n=11) |
|
| 8 hours from D38 dose (n=11) |
|
| 12 hours from D38 dose (n=11) |
|
| 20 hours from D38 dose (n=11) |
|
| 32 hours from D38 dose (n=11) |
|
| 42 hours from D38 dose (n=11) |
|
| 48 hours from D38 dose (n=11) |
|
| 49 hours from D38 dose (n=11) |
|
| 114 hours from D38 dose (n=11) |
|
| Title | Measurements |
|---|---|
|
| 4 hours from D1 dose (n=12) |
|
| 8 hours from D1 dose (n=12) |
|
| 12 hours from D1 dose (n=12) |
|
| 20 hours from D1 dose (n=12) |
|
| 32 hours from D1 dose (n=12) |
|
| 42 hours from D1 dose (n=12) |
|
| 48 hours from D1 dose (n=12) |
|
| 49 hours from D1 dose (n=12) |
|
| 90 hours from D1 dose (n=12) |
|
| 0 hours from D38 dose (n=11) |
|
| 1 hour from D38 dose (n=11) |
|
| 2 hours from D38 dose (n=11) |
|
| 4 hours from D38 dose (n=11) |
|
| 8 hours from D38 dose (n=11) |
|
| 12 hours from D38 dose (n=11) |
|
| 20 hours from D38 dose (n=11) |
|
| 32 hours from D38 dose (n=11) |
|
| 42 hours from D38 dose (n=11) |
|
| 48 hours from D38 dose (n=11) |
|
| 49 hours from D38 dose (n=11) |
|
| 114 hours from D38 dose (n=11) |
|
| Title | Measurements |
|---|---|
|
| Arterial: 5 hours (Day 3) |
|
| Venous: 1 hour (Day 3) |
|
| Venous: 2 hours (Day 3) |
|
| Venous: 4 hours (Day 3) |
|
| Venous: 5 hours (Day 3) |
|
| Arterial: 1 hour (Day 40) |
|
| Arterial: 2 hours (Day 40) |
|
| Arterial: 4 hours (Day 40) |
|
| Arterial: 5 hours (Day 40) |
|
| Venous: 1 hour (Day 40) |
|
| Venous: 2 hours (Day 40) |
|
| Venous: 4 hours (Day 40) |
|
| Venous: 5 hours (Day 40) |
|
| Title | Measurements |
|---|---|
|
| 4 hours from D1 dose |
|
| 8 hours from D1 dose |
|
| 12 hours from D1 dose |
|
| 24 hours from D1 dose |
|
| 48 hours from D1 dose |
|
| 72 hours from D1 dose |
|
| 120 hours from D1 dose |
|
| 0 hours from D36 dose |
|
| 1 hour from D36 dose |
|
| 2 hours from D36 dose |
|
| 4 hours from D36 dose |
|
| 8 hours from D36 dose |
|
| 12 hours from D36 dose |
|
| 24 hours from D36 dose |
|
| 48 hours from D36 dose |
|
| 72 hours from D36 dose |
|
| 120 hours from D36 dose |
|
| 168 hours from D36 dose |
|
| Title | Measurements |
|---|---|
|
| 4 hours from D1 dose |
|
| 8 hours from D1 dose |
|
| 12 hours from D1 dose |
|
| 24 hours from D1 dose |
|
| 48 hours from D1 dose |
|
| 72 hours from D1 dose |
|
| 120 hours from D1 dose |
|
| 0 hours from D36 dose |
|
| 1 hour from D36 dose |
|
| 2 hours from D36 dose |
|
| 4 hours from D36 dose |
|
| 8 hours from D36 dose |
|
| 12 hours from D36 dose |
|
| 24 hours from D36 dose |
|
| 48 hours from D36 dose |
|
| 72 hours from D36 dose |
|
| 120 hours from D36 dose |
|
| 168 hours from D36 dose |
|