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Pyrimethamine in combination with a sulphonamide is known to be effective in the treatment of toxoplasmosis. However, Pyrimethamine has not been approved by the Japanese regulatory body (Pharmaceutical and Medical Devices Agency [PMDA]/ Ministry of Health, Labor and Welfare [MHLW]). The pharmacokinetics (PK) of Pyrimethamine has been investigated following administration of Sulfadoxine/Pyrimethamine tablet in healthy Japanese subjects. However, the study did not provide sufficient information for approval of Pyrimethamine in Japan; hence, PMDA has requested confirmation of the PK of Pyrimethamine in another PK study in Japanese and Caucasian healthy subjects. This study will be a single centre, open-label, parallel-group, single oral dose study to evaluate the PK, safety and tolerability of Pyrimethamine in healthy Japanese and Caucasian male subjects. Subjects will undergo a screening visit within 30 days prior to first dose of the study drug. On Day 1, subjects will be administered a single oral dose of pyrimethamine 50 milligrams (mg) along with calcium folinate 15 mg after an overnight fast of at least 10 hours. Subjects will continue to receive calcium folinate once daily until Day 8 of the treatment period. Blood sampling for PK analysis and safety assessments will be performed prior to dosing and over 22 days after dosing. Each subject will participate in the study for approximately 2 months from screening to follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Japanese male subjects | Experimental | Healthy Japanese male subjects will receive a single oral dose of Pyrimethamine 50 mg in the fasted state co-administered with calcium folinate 15 mg on Day 1. Oral calcium folinate will be administered once daily until Day 8. Blood samples for PK analysis will be collected prior to administering first dose of Pyrimethamine and over 22 days post dose. Each subject will participate in the study for a duration of approximately 2 months from screening to follow-up. |
|
| Healthy Caucasian male subjects | Experimental | Healthy Caucasian male subjects will receive a single oral dose of Pyrimethamine 50 mg in the fasted state co-administered with calcium folinate 15 mg on Day 1. Oral calcium folinate will be administered once daily until Day 8. Blood samples for PK analysis will be collected prior to administering first dose of Pyrimethamine and over 22 days post dose. Each subject will participate in the study for a duration of approximately 2 months from screening to follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrimethamine | Drug | Pyrimethamine will be available as 25 mg tablets. Subjects will be orally administered two pyrimethamine tablets on Day 1 in a fasted condition with 240 mL of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. PK Population is defined as all participants who administered at least one dose of study treatment and who have PK sample taken and analyzed. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Area Under the Concentration-time Curve From Time 0 to t (AUC[0-t]) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Area Under the Concentration-time Curve From Time 0 to 24 (AUC[0-24]) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Terminal Half-life (t1/2) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| AUC (0-t) of Pyrimethamine in Healthy Caucasian Male Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31950646 | Background | Iida T, Nand RA, Ino H, Ogura H, Itoh H, Igarashi H, Numachi Y, Gross AS. Evaluation of the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Pyrimethamine in Healthy Male Subjects of Japanese and European Ancestry. Clin Pharmacol Drug Dev. 2020 Aug;9(6):768-773. doi: 10.1002/cpdd.771. Epub 2020 Jan 16. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 14 healthy participants were enrolled in this study.
This study was conducted in healthy Japanese and Caucasian male participants to evaluate safety, tolerability and pharmacokinetic (PK) parameters of Pyrimethamine. This study was conducted at a single center in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Japanese Participants | Healthy Japanese male participants received a single oral dose of Pyrimethamine 50 milligram (mg) tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 milliliters (mL) of water. |
| FG001 | Healthy Caucasian Participants | Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Japanese Participants | Healthy Japanese male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water. |
| BG001 |
| 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 Observed Concentration (Cmax) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. PK Population is defined as all participants who administered at least one dose of study treatment and who have PK sample taken and analyzed. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
|
Serious adverse events (SAEs) and non-serious AEs were collected up to Day 23
Non-serious AEs and SAEs for Safety Population was reported
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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 | Healthy Japanese Participants | Healthy Japanese male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Folliculitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2017 | Jul 12, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2017 | Jul 12, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014123 | Toxoplasmosis |
| ID | Term |
|---|---|
| D003048 | Coccidiosis |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011739 | Pyrimethamine |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
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| Calcium folinate | Drug | Calcium folinate will be available as 5 mg tablets. Subjects will be orally administered three calcium folinate tablets on Day 1 along with pyrimethamine followed by once daily administration of calcium folinate until Day 8. Each administration will be with 240 mL water. |
|
| Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Time to Maximum Observed Concentration (Tmax) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Apparent Clearance Following Oral Dosing (CL/F) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Apparent Volume of Distribution Following Oral Dosing (Vd/F) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. |
| Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| AUC (0-inf) of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| AUC (0-24) of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Tmax of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| T1/2 of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| CL/F of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Vd/F of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants who take at least one dose of study treatment were included in Safety Population. | Up to Day 23 |
| Change From Baseline of Clinical Chemistry Parameters: Glucose, Sodium, Calcium, Potassium, and Urea. | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, sodium, calcium, potassium, and urea at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) | Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphatase, ALT and AST at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline of Clinical Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine. | Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, bilirubin and creatinine at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline of Clinical Chemistry Parameters: Protein | Blood samples were collected for the analysis of clinical chemistry parameter including protein at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and Leukocytes | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. Data was not available as all basophil values were below the detection limit. Hence, the change from baseline in basophil values were not calculated. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Hematology Parameter: Reticulocytes | Blood samples were collected for the analysis of hematology parameter including reticulocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected for the analysis of hematology parameter including hematocrit at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Blood samples were collected for the analysis of hematology parameter including mean corpuscular hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Volume | Blood samples were collected for the analysis of hematology parameter including mean corpuscular volume at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Hematology Parameter: Erythrocytes | Blood samples were collected for the analysis of hematology parameter including erythrocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
| Number of Participants With Abnormal Urinalysis Parameter | The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of can be read as Trace, + and ++ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. | Day -1, 24, 96, 168, 336 and follow up (504 hours) |
| Specific Gravity at Indicated Time Points | Urine samples were collected for analysis of specific gravity of urine. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. | Day -1, 24, 96, 168, 336 hours and follow up (504 hours) |
| Urine Potential of Hydrogen (pH) at Indicated Time Points | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Day -1, 24, 96, 168, 336 hours and follow up (504 hours) |
| Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours |
| Change From Baseline in Pulse Rate | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours |
| Change From Baseline in Temperature | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours |
| Change From Baseline of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, and QT Interval Corrected for Heart Rate by Fredericia's Formula (QTcF) Interval | A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically measures PR, QRS, QT, and QTcF intervals. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours |
| Change From Baseline of ECG Parameter: ECG Mean Heart Rate | A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically calculates mean ECG heart rate. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours |
| Healthy Caucasian Participants |
Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Primary | Area Under the Concentration-time Curve From Time 0 to t (AUC[0-t]) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
|
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| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
|
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| Primary | Area Under the Concentration-time Curve From Time 0 to 24 (AUC[0-24]) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
|
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| Primary | Terminal Half-life (t1/2) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
|
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| Primary | Time to Maximum Observed Concentration (Tmax) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Median | Full Range | Hours | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Primary | Apparent Clearance Following Oral Dosing (CL/F) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliter per hour | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Primary | Apparent Volume of Distribution Following Oral Dosing (Vd/F) of Pyrimethamine in Healthy Japanese Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
|
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| Secondary | Cmax of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | AUC (0-t) of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | AUC (0-inf) of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | AUC (0-24) of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | Tmax of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Median | Full Range | Hours | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | T1/2 of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Mean | Standard Deviation | Hours | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | CL/F of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters per hour | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | Vd/F of Pyrimethamine in Healthy Caucasian Male Participants | Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters | Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22 |
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| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants who take at least one dose of study treatment were included in Safety Population. | Safety Population | Posted | Count of Participants | Participants | Up to Day 23 |
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|
|
| Secondary | Change From Baseline of Clinical Chemistry Parameters: Glucose, Sodium, Calcium, Potassium, and Urea. | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, sodium, calcium, potassium, and urea at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) | Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphatase, ALT and AST at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline of Clinical Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine. | Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, bilirubin and creatinine at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline of Clinical Chemistry Parameters: Protein | Blood samples were collected for the analysis of clinical chemistry parameter including protein at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Gram per liter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and Leukocytes | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. Data was not available as all basophil values were below the detection limit. Hence, the change from baseline in basophil values were not calculated. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Reticulocytes | Blood samples were collected for the analysis of hematology parameter including reticulocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Proportion of reticulocytes in blood | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected for the analysis of hematology parameter including hematocrit at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Gram per liter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Blood samples were collected for the analysis of hematology parameter including mean corpuscular hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Picogram | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume | Blood samples were collected for the analysis of hematology parameter including mean corpuscular volume at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes | Blood samples were collected for the analysis of hematology parameter including erythrocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Number of Participants With Abnormal Urinalysis Parameter | The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of can be read as Trace, + and ++ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. | Safety Population | Posted | Count of Participants | Participants | Day -1, 24, 96, 168, 336 and follow up (504 hours) |
|
|
|
| Secondary | Specific Gravity at Indicated Time Points | Urine samples were collected for analysis of specific gravity of urine. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Ratio | Day -1, 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Urine Potential of Hydrogen (pH) at Indicated Time Points | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | pH | Day -1, 24, 96, 168, 336 hours and follow up (504 hours) |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours |
|
|
|
| Secondary | Change From Baseline in Pulse Rate | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours |
|
|
|
| Secondary | Change From Baseline in Temperature | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Celsius | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours |
|
|
|
| Secondary | Change From Baseline of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, and QT Interval Corrected for Heart Rate by Fredericia's Formula (QTcF) Interval | A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically measures PR, QRS, QT, and QTcF intervals. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Millisecond | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours |
|
|
|
| Secondary | Change From Baseline of ECG Parameter: ECG Mean Heart Rate | A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically calculates mean ECG heart rate. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Healthy Caucasian Participants | Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water. | 0 | 7 | 0 | 7 | 6 | 7 |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| Glucose, 96 hours, n=7, 7 |
|
|
| Glucose, 168 hours, n=7, 7 |
|
|
| Category title 4. : Glucose, 336 hours, n=7, 7 |
|
|
| Glucose, Follow-up (504 hours), n= 7, 6 |
|
|
| Calcium, 24 hours, n=7, 7 |
|
|
| Calcium, 96 hours, n=7, 7 |
|
|
| Calcium, 168 hours, n=7, 7 |
|
|
| Calcium, 336 hours, n=7, 7 |
|
|
| Calcium, Follow up (504 hours), n=7, 6 |
|
|
| Potassium, 24 hours, n=7, 7 |
|
|
| Potassium, 96 hours, n=7, 7 |
|
|
| Potassium, 168 hours, n=7, 7 |
|
|
| Potassium, 336 hours, n=7, 7 |
|
|
| Potassium, Follow up (504 hours), n=7, 6 |
|
|
| Sodium, 24 hours, n=7, 7 |
|
|
| Sodium, 96 hours, n=7, 7 |
|
|
| Sodium, 168 hours, n=7, 7 |
|
|
| Sodium, 336 hours, n=7, 7 |
|
|
| Sodium, Follow up (504 hours), n=7, 6 |
|
|
| Urea, 24 hours, n=7, 7 |
|
|
| Urea, 96 hours, n=7, 7 |
|
|
| Urea, 168 hours, n=7, 7 |
|
|
| Urea, 336 hours, n=7, 7 |
|
|
| Urea, Follow up,(504 hours) n=7, 6 |
|
|
| Alkaline Phosphatase, 96 hours, n=7, 7 |
|
|
| Alkaline Phosphatase, 168 hours, n=7, 7 |
|
|
| Alkaline Phosphatase, 336 hours, n=7, 7 |
|
|
| Alkaline Phosphatase, Follow-up (504 hours), n=7,6 |
|
|
| ALT, 24 hours, n=7, 7 |
|
|
| ALT, 96 hours, n=7, 7 |
|
|
| ALT, 168 hours, n=7, 7 |
|
|
| ALT, 336 hours, n=7, 7 |
|
|
| ALT, Follow up (504 hours), n=7, 6 |
|
|
| AST, 24 hours, n=7, 7 |
|
|
| AST, 96 hours, n=7, 7 |
|
|
| AST, 168 hours, n=7, 7 |
|
|
| AST, 336 hours, n=7, 7 |
|
|
| AST, Follow up (504 hours), n=7, 6 |
|
|
| Direct bilirubin, 96 hours, n=7, 7 |
|
|
| Direct bilirubin, 168 hours, n=7, 7 |
|
|
| Direct bilirubin, 336 hours, n=7, 7 |
|
|
| Direct bilirubin, Follow-up (504 hours), n=7, 6 |
|
|
| Bilirubin, 24 hours, n=7, 7 |
|
|
| Bilirubin, 96 hours, n=7, 7 |
|
|
| Bilirubin, 168 hours, n=7, 7 |
|
|
| Bilirubin, 336 hours, n=7, 7 |
|
|
| Bilirubin, Follow up (504 hours), n=7, 6 |
|
|
| Creatinine, 24 hours, n=7, 7 |
|
|
| Creatinine, 96 hours, n=7, 7 |
|
|
| Creatinine, 168 hours, n=7, 7 |
|
|
| Creatinine, 336 hours, n=7, 7 |
|
|
| Creatinine, Follow up (504 hours), n=7, 6 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n=7, 7 |
|
|
| Follow-up (504 hours), n=7, 6 |
|
|
| Basophils, 168 hours, n=0, 0 |
|
| Basophils, 336 hours, n=0, 0 |
|
| Basophils, Follow up (504 hours), n=0, 0 |
|
| Eosinophils, 24 hours, n=4, 3 |
|
|
| Eosinophils, 96 hours, n=4, 3 |
|
|
| Eosinophils, 168 hours, n=4, 3 |
|
|
| Eosinophils, 336 hours, n=3, 3 |
|
|
| Eosinophils, Follow up (504 hours), n=4, 2 |
|
|
| Lymphocytes, 24 hours, n=7, 7 |
|
|
| Lymphocytes, 96 hours, n=7, 7 |
|
|
| Lymphocytes, 168 hours, n=7, 7 |
|
|
| Lymphocytes, 336 hours, n=7, 7 |
|
|
| Lymphocytes, Follow up (504 hours), n=7, 6 |
|
|
| Monocytes, 24 hours, n=7, 7 |
|
|
| Monocytes, 96 hours, n=7, 7 |
|
|
| Monocytes, 168 hours, n=7, 7 |
|
|
| Monocytes, 336 hours, n=7, 7 |
|
|
| Monocytes, Follow up (504 hours), n=7, 6 |
|
|
| Neutrophils, 24 hours, n=7, 7 |
|
|
| Neutrophils, 96 hours, n=7, 7 |
|
|
| Neutrophils, 168 hours, n=7, 7 |
|
|
| Neutrophils, 336 hours, n=7, 7 |
|
|
| Neutrophils, Follow up (504 hours), n=7, 6 |
|
|
| Platelet, 24 hours, n=7, 7 |
|
|
| Platelet, 96 hours, n=7, 7 |
|
|
| Platelet, 168 hours, n=7, 7 |
|
|
| Platelet, 336 hours, n=7, 7 |
|
|
| Platelet, Follow up (504 hours), n=7, 6 |
|
|
| Leukocytes, 24 hours, n=7, 7 |
|
|
| Leukocytes, 96 hours, n=7, 7 |
|
|
| Leukocytes, 168 hours, n=7, 7 |
|
|
| Leukocytes, 336 hours, n=7, 7 |
|
|
| Leukocytes, Follow up (504 hours), n=7, 6 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n= 7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n= 7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n= 7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n= 7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n= 7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n= 7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| Ketones, follow up (504 hours), + |
|
| Occult blood, 336 hours, + |
|
| Occult blood, follow up, trace |
|
| Protein, Day -1, trace |
|
| Protein, 24 hours, trace |
|
| Protein, 96 hours, trace |
|
| Protein, 168 hours, trace |
|
| Protein, 336 hours, trace |
|
| 24 hours, n=7, 7 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n=7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| 24 hours, n=7, 7 |
|
|
| 96 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n=7, 7 |
|
|
| Follow up (504 hours), n=7, 6 |
|
|
| DBP, 12 hours, n=7, 7 |
|
|
| DBP, 24 hours, n=7, 7 |
|
|
| DBP, 48 hours, n=7, 7 |
|
|
| DBP, 72 hours, n=7, 7 |
|
|
| DBP, 96 hours, n=7, 7 |
|
|
| DBP, 120 hours, n=7, 7 |
|
|
| DBP, 144 hours, n=7, 7 |
|
|
| DBP, 168 hours, n=7, 7 |
|
|
| DBP, 336 hours, n=7, 7 |
|
|
| DBP, 504 hours, n=7, 6 |
|
|
| SBP, 4 hours, n=7, 7 |
|
|
| SBP, 12 hours, n=7, 7 |
|
|
| SBP, 24 hours, n=7, 7 |
|
|
| SBP, 48 hours, n=7, 7 |
|
|
| SBP, 72 hours, n=7, 7 |
|
|
| SBP, 96 hours, n=7, 7 |
|
|
| SBP, 120 hours, n=7, 7 |
|
|
| SBP,144 hours, n=7, 7 |
|
|
| SBP, 168 hours, n=7, 7 |
|
|
| SBP, 336 hours, n=7, 7 |
|
|
| SBP, 504 hours, n=7, 6 |
|
|
| 12 hours, n=7, 7 |
|
|
| 24 hours, n=7, 7 |
|
|
| 48 hours, n=7, 7 |
|
|
| 72 hours, n=7, 7 |
|
|
| 96 hours, n=7, 7 |
|
|
| 120 hours, n=7, 7 |
|
|
| 144 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n=7, 7 |
|
|
| 504 hours, n=7, 6 |
|
|
| 12 hours, n=7, 7 |
|
|
| 24 hours, n=7, 7 |
|
|
| 48 hours, n=7, 7 |
|
|
| 72 hours, n=7, 7 |
|
|
| 96 hours, n=7, 7 |
|
|
| 120 hours, n=7, 7 |
|
|
| 144 hours, n=7, 7 |
|
|
| 168 hours, n=7, 7 |
|
|
| 336 hours, n=7, 7 |
|
|
| 504 hours, n=7, 6 |
|
|
| PR Interval, 12 hours, n=7, 7 |
|
|
| PR Interval, 24 hours, n=7, 7 |
|
|
| PR Interval, 48 hours, n=7, 7 |
|
|
| PR Interval, 504 hours, n=7, 6 |
|
|
| QRS duration, 4 hours, n=7, 7 |
|
|
| QRS duration, 12 hours, n=7, 7 |
|
|
| QRS duration, 24 hours, n=7, 7 |
|
|
| QRS duration, 48 hours, n=7, 7 |
|
|
| QRS duration, 504 hours, n=7, 6 |
|
|
| QT interval, 4 hours, n=7, 7 |
|
|
| QT interval, 12 hours, n=7, 7 |
|
|
| QT interval, 24 hours, n=7, 7 |
|
|
| QT interval, 48 hours, n=7, 7 |
|
|
| QT interval, 504 hours, n=7, 6 |
|
|
| QTcF interval, 4 hours, n=7, 7 |
|
|
| QTcF interval, 12 hours, n=7, 7 |
|
|
| QTcF interval, 24 hours, n=7, 7 |
|
|
| QTcF interval, 48 hours, n=7, 7 |
|
|
| QTcF interval, 504 hours, n=7, 6 |
|
|
| 12 hours, n=7, 7 |
|
|
| 24 hours, n=7, 7 |
|
|
| 48 hours, n=7, 7 |
|
|
| 504 hours, n=7, 6 |
|
|