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This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteers on dialysis | Experimental |
| |
| Volunteers with reduced creatinine clearance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamiflu (oseltamivir) | Drug | Single dose of Tamiflu in volunteers on dialysis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose | CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose. CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed[0-48])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC[0-48]) CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed[0-8]/AUC[0-8] + Aed[24-32]/AUC[24-32]) / 2 CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed[8-16]/AUC[8-16] + Aed[16-24]/AUC[16-24] + Aed[32-48]/AUC[32-48]) / 3 | CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood |
| AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose | AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
| AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose | AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. |
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Inclusion Criteria:
General
Volunteers on dialysis
Volunteers with reduced creatinine clearance
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 | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25289522 | Derived | Patel K, Rayner CR, Giraudon M, Kamal MA, Morcos PN, Robson R, Kirkpatrick CM. Pharmacokinetics and safety of oseltamivir in patients with end-stage renal disease treated with automated peritoneal dialysis. Br J Clin Pharmacol. 2015 Apr;79(4):624-35. doi: 10.1111/bcp.12526. |
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A total of 27 participants were screened and 16 participants were enrolled in the study. The study was conducted from 09 March 2012 to 23 June 2012 at two study centers in New Zealand.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dialysis (Oseltamivir 75 mg) | Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule. |
| FG001 | Reduced Creatinine Clearance (Oseltamivir 30 mg) | Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dialysis (Oseltamivir 75 mg) | Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule. |
| BG001 | Reduced Creatinine Clearance (Oseltamivir 30 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose | CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose. CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed[0-48])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC[0-48]) CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed[0-8]/AUC[0-8] + Aed[24-32]/AUC[24-32]) / 2 CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed[8-16]/AUC[8-16] + Aed[16-24]/AUC[16-24] + Aed[32-48]/AUC[32-48]) / 3 | Pharmacokinetic (PK) population: Only 9 participants were included for this analysis as they did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or if data was unavailable or incomplete which influence the PK analysis were excluded from the PK analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre (L)/hour (h) | CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood |
Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
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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 | Dialysis (Oseltamivir 75 mg) | Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
Not provided
| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Tamiflu (oseltamivir) |
| Drug |
Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min |
|
| Cmax of Oseltamivir and Oseltamivir Carboxylate | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
| C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose | C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
| Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate | The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration. The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
| Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate | CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t). | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine. |
| Approximately 7 weeks |
| Number of Participants With Marked Abnormality in Laboratory Measurements | Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase [ALT], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis. Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L. | Approximately 7 weeks |
| Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit | ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond [msec]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as <=30, >30-60, and >60 msec increase from baseline. | From Baseline (Day -1) to Follow-up visit (Days 15 to 22) |
| Number of Participants With Abnormal Shifts in Vital Signs | Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature. Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as <=70 mmHg (SBP) and <=40 mmHg (DBP); high blood pressure defined as >=140 mmHg (SBP) and >=90 mmHg (DBP); low temperature defined as <=36.5 degrees Celsius and high temperature defined as >=37.5 degrees Celsius. | Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22) |
| Grafton |
| 1010 |
| New Zealand |
Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. | Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included. | Posted | Number | participants | Approximately 7 weeks |
|
|
|
| Primary | AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose | AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n". | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram (ng)*h/ milliliter (mL) | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
|
|
|
| Primary | AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose | AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n". | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
|
|
|
| Primary | Cmax of Oseltamivir and Oseltamivir Carboxylate | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n". | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
|
|
|
| Primary | C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose | C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
|
|
|
| Primary | Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate | The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration. The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir. | PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n". | Posted | Median | Full Range | h | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose |
|
|
|
| Primary | Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate | CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t). | PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n". | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine. |
|
|
|
| Secondary | Number of Participants With Marked Abnormality in Laboratory Measurements | Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase [ALT], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis. Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L. | Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included. | Posted | Number | participants | Approximately 7 weeks |
|
|
|
| Secondary | Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit | ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond [msec]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as <=30, >30-60, and >60 msec increase from baseline. | Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included. | Posted | Number | participants | From Baseline (Day -1) to Follow-up visit (Days 15 to 22) |
|
|
|
| Secondary | Number of Participants With Abnormal Shifts in Vital Signs | Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature. Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as <=70 mmHg (SBP) and <=40 mmHg (DBP); high blood pressure defined as >=140 mmHg (SBP) and >=90 mmHg (DBP); low temperature defined as <=36.5 degrees Celsius and high temperature defined as >=37.5 degrees Celsius. | Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included. | Posted | Number | participants | Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22) |
|
|
|
| 1 |
| 10 |
| 9 |
| 10 |
| EG001 | Reduced Creatinine Clearance (Oseltamivir 30 mg) | Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule. | 0 | 6 | 2 | 6 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Catheter site hematoma | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Parasthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | 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.
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| AUC120 oseltamivir carboxylate (n = 9) |
|
| AUC168 oseltamivir carboxylate (n = 9) |
|
| AUCinf oseltamivir carboxylate (n = 9) |
|
| Clast, oseltamivir |
|
| C120h, oseltamivir carboxylate |
|
| C168h,oseltamivir carboxylate |
|
| Clast, oseltamivir carboxylate |
|
| Tmax, Oseltamivir carboxylate (n = 9, 6) |
|
| T1/2, Oseltamivir Carboxylate (n = 9,6) |
|
| Phosphate |
|
| Calcium |
|
| Glucose (random) |
|
| Bicarbonate |
|
| ALT |
|
| QTcB, <= 30 |
|
| QTcF, <= 30 |
|
| QTcF, > 30 - 60 |
|
| SBP, Day 3, High |
|
| SBP, Day 4, High |
|
| SBP, Day 5, High |
|
| SBP, Day 7, High |
|
| SBP, Day 8, High |
|
| SBP, Follow Up, High |
|
| DBP, Day 2, High |
|
| DBP, Day 3, High |
|
| DBP, Day 7, High |
|
| DBP, Day 8, High |
|
| DBP, Follow Up, High |
|
| Temperature, Day 4, Low |
|
| Temperature, Day 6, Low |
|
| Temperature, Day 7, Low |
|
| Temperature, Day 8, Low |
|
| Temperature, Follow Up, Low |
|