ID

29728

Descripción

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Follow-up

Palabras clave

Versiones (2)
  1. 5/4/18 5/4/18 -
  2. 16/4/18 16/4/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects GSK102587

Inglés

Follow-up

1 formularios  
  1. StudyEvent: ODM
    1. Follow-up
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Vital Signs Date
Descripción

Vital Signs Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826644
Actual Time Vital Signs
Descripción

Actual Time Vital Signs

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure systolic
Descripción

Blood Pressure systolic

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure diastolic
Descripción

Blood Pressure diastolic

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Drug and Alcohol Screen
Descripción

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0038586
UMLS CUI-3
C0948726
Date sample taken Drug and Alcohol Screen
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1302413
Time sample taken Drug and Alcohol Screen
Descripción

Time sample taken

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Cocaine
Descripción

Cocaine

Tipo de datos

integer

Alias
UMLS CUI [1]
C0009170
Amphetamines
Descripción

Amphetamines

Tipo de datos

integer

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Descripción

Benzodiazepines

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005064
Cannabis metabolites
Descripción

Cannabis metabolites

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0936079
UMLS CUI [1,2]
C0870883
Opiates
Descripción

Opiates

Tipo de datos

integer

Alias
UMLS CUI [1]
C0376196
Barbiturates
Descripción

Barbiturates

Tipo de datos

integer

Alias
UMLS CUI [1]
C0004745
PCP
Descripción

PCP

Tipo de datos

integer

Alias
UMLS CUI [1]
C0031381
Alcohol
Descripción

If any of the above are positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0202304
UMLS CUI [2]
C0001948
Local Laboratory - Haematology
Descripción

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Lab ID
Descripción

Lab ID

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Date Sample taken Haematology
Descripción

Date Sample taken Haematology

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1302413
Time sample taken Haematology
Descripción

Time sample taken Haematology

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0040223
Planned Relative Time Haematology
Descripción

Planned Relative Time Haematology

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0439564
Haemoglobin (Hb)
Descripción

Haemoglobin (Hb)

Tipo de datos

text

Alias
UMLS CUI [1]
C0518015
Haematocrit (HCT)
Descripción

Haematocrit (HCT)

Tipo de datos

text

Alias
UMLS CUI [1]
C0018935
Platelet count (absolute)
Descripción

Platelet count (absolute)

Tipo de datos

text

Alias
UMLS CUI [1]
C0032181
White blood cell count (WBC) (Absolute)
Descripción

White blood cell count (WBC) (Absolute)

Tipo de datos

text

Alias
UMLS CUI [1]
C0023508
Neutrophil count (absolute)
Descripción

Neutrophil count (absolute)

Tipo de datos

text

Alias
UMLS CUI [1]
C0948762
Lymphocyte count (absolute)
Descripción

Lymphocyte count (absolute)

Tipo de datos

text

Alias
UMLS CUI [1]
C3544087
Monocyte count (absolute)
Descripción

Monocyte count (absolute)

Tipo de datos

text

Alias
UMLS CUI [1]
C0200637
Eosinophil count (absolute)
Descripción

Eosinophil count (absolute)

Tipo de datos

text

Alias
UMLS CUI [1]
C0200638
Basophil count (absolute)
Descripción

Basophil count (absolute)

Tipo de datos

text

Alias
UMLS CUI [1]
C0200641
Local Laboratory - Clinical Chemistry
Descripción

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Lab ID
Descripción

Lab ID

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Date sample taken clinical chemistry
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1302413
Time Sample Taken Clinical Chemistry
Descripción

Time Sample Taken

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Planned Relative Time Clinical Chemistry
Descripción

Planned Relative Time

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0439564
Sodium
Descripción

Sodium

Tipo de datos

float

Alias
UMLS CUI [1]
C0337443
Potassium
Descripción

Potassium

Tipo de datos

float

Alias
UMLS CUI [1]
C0202194
Calcium
Descripción

Calcium

Tipo de datos

float

Alias
UMLS CUI [1]
C0201925
Glucose (fasting)
Descripción

Glucose (fasting)

Tipo de datos

float

Alias
UMLS CUI [1]
C0583513
Total Protein
Descripción

Total Protein

Tipo de datos

float

Alias
UMLS CUI [1]
C0555903
Albumin
Descripción

Albumin

Tipo de datos

float

Alias
UMLS CUI [1]
C0201838
Total bilirubin
Descripción

Total bilirubin

Tipo de datos

float

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase
Descripción

Alkaline phosphatase

Tipo de datos

float

Alias
UMLS CUI [1]
C0201850
AST (SGOT)
Descripción

AST (SGOT)

Tipo de datos

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Descripción

ALT (SGPT)

Tipo de datos

float

Alias
UMLS CUI [1]
C0201836
Serum Creatinine
Descripción

Serum Creatinine

Tipo de datos

float

Alias
UMLS CUI [1]
C0201976
Blood Urea Nitrogen
Descripción

BUN

Tipo de datos

float

Alias
UMLS CUI [1]
C0005845
LDH
Descripción

LDH

Tipo de datos

float

Alias
UMLS CUI [1]
C0202113
Creatine Phosphokinase (CPK)
Descripción

Creatine Phosphokinase (CPK)

Tipo de datos

float

Alias
UMLS CUI [1]
C0201973
Urinalysis
Descripción

Urinalysis

Alias
UMLS CUI-1
C0042014
Lab ID
Descripción

Lab ID

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
UMLS CUI [2]
C0042014
Date sample taken Urinalysis
Descripción

Date sample taken Urinalysis

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
Time sample taken Urinalysis
Descripción

Time sample taken Urinalysis

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
Specific gravity
Descripción

Urine Specific Gravity

Tipo de datos

float

Alias
UMLS CUI [1]
C0202517
pH
Descripción

Urine pH

Tipo de datos

float

Alias
UMLS CUI [1]
C0042044
Glucose
Descripción

Urine Glucose

Tipo de datos

float

Alias
UMLS CUI [1]
C0004076
Protein
Descripción

Urine Protein

Tipo de datos

float

Alias
UMLS CUI [1]
C0262923
Blood
Descripción

Hematuria

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0018965
UMLS CUI [1,2]
C0042014
Ketones
Descripción

Urine Ketones

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0042014
Was sedimentary microscopy performed?
Descripción

sedimentary microscopy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Red Blood Cells
Descripción

RBC

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C2700128
White blood cells
Descripción

White blood cells

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C2700128
Hyaline casts
Descripción

Hyaline casts

Tipo de datos

float

Alias
UMLS CUI [1]
C0427894
Granular casts
Descripción

Granular casts

Tipo de datos

float

Alias
UMLS CUI [1,1]
C2697521
UMLS CUI [1,2]
C2700128
Cellular casts
Descripción

Cellular casts

Tipo de datos

float

Alias
UMLS CUI [1,1]
C2699157
UMLS CUI [1,2]
C2700128
Crystals
Descripción

Crystals

Tipo de datos

float

Alias
UMLS CUI [1]
C1287304
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Similar models

Follow-up

1 formularios
  1. StudyEvent: ODM
    1. Follow-up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Actual Time Vital Signs
Item
Actual Time Vital Signs
time
C2826762 (UMLS CUI [1])
Blood Pressure systolic
Item
Blood Pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure diastolic
Item
Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
Date sample taken
Item
Date sample taken Drug and Alcohol Screen
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken Drug and Alcohol Screen
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cocaine
integer
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
positive (1)
CL Item
negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Cocaine
Code List
Amphetamines
CL Item
positive (1)
CL Item
negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Cocaine
Code List
Benzodiazepines
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabis metabolites
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
Cocaine
Code List
Cannabis metabolites
CL Item
positive (1)
CL Item
negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Cocaine
Code List
Opiates
CL Item
positive (1)
CL Item
negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Cocaine
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
PCP
integer
C0031381 (UMLS CUI [1])
Cocaine
Code List
PCP
CL Item
positive (1)
CL Item
negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
C0001948 (UMLS CUI [2])
Cocaine
Code List
Alcohol
CL Item
positive (1)
CL Item
negative (2)
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time sample taken Haematology
Item
Time sample taken Haematology
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Haematology
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time Haematology
Code List
Planned Relative Time Haematology
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit (HCT)
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
text
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
text
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
text
C3544087 (UMLS CUI [1])
Monocyte count (absolute)
Item
Monocyte count (absolute)
text
C0200637 (UMLS CUI [1])
Eosinophil count (absolute)
Item
Eosinophil count (absolute)
text
C0200638 (UMLS CUI [1])
Basophil count (absolute)
Item
Basophil count (absolute)
text
C0200641 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Sample Taken
Item
Time Sample Taken Clinical Chemistry
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Clinical Chemistry
integer
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time Haematology
Code List
Planned Relative Time Clinical Chemistry
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Creatine Phosphokinase (CPK)
Item
Creatine Phosphokinase (CPK)
float
C0201973 (UMLS CUI [1])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Date sample taken Urinalysis
Item
Date sample taken Urinalysis
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time sample taken Urinalysis
Item
Time sample taken Urinalysis
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urine Specific Gravity
Item
Specific gravity
float
C0202517 (UMLS CUI [1])
Urine pH
Item
pH
float
C0042044 (UMLS CUI [1])
Urine Glucose
Item
Glucose
float
C0004076 (UMLS CUI [1])
Urine Protein
Item
Protein
float
C0262923 (UMLS CUI [1])
Hematuria
Item
Blood
float
C0018965 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Urine Ketones
Item
Ketones
float
C1991100 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
sedimentary microscopy
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
RBC
Item
Red Blood Cells
float
C0014772 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
White blood cells
Item
White blood cells
float
C0023508 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Hyaline casts
Item
Hyaline casts
float
C0427894 (UMLS CUI [1])
Granular casts
Item
Granular casts
float
C2697521 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Cellular casts
Item
Cellular casts
float
C2699157 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Crystals
Item
Crystals
float
C1287304 (UMLS CUI [1])
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