ID
40801
Descripción
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis) Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).
Palabras clave
Versiones (1)
- 15/5/20 15/5/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
15 de mayo de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)
Descripción
Local Laboratory Result Data - [Clinical Chemistry]
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Descripción
Date and time sample taken - clinical chemistry
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0523961
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201975
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201838
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0337438
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0202194
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0337443
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201925
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201950
- UMLS CUI [1,2]
- C0005768
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0202236
- UMLS CUI [1,2]
- C0005768
Descripción
Laboratory result data - [Haematology]
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Descripción
Date and time sample taken - haematology
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0518015
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0014772
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1948043
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1261502
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0474535
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0018935
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0032181
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0023508
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0948762
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3544087
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0200637
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0200638
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0200641
Descripción
Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0584609
- UMLS CUI [1,2]
- C0549177
- UMLS CUI [1,3]
- C0007584
Descripción
Urinalysis (Dipstick) Test
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Descripción
Date and time sample taken - Urinalysis
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Descripción
Protein Urine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0262923
Descripción
Glucose Urine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0004076
Descripción
Ketones Urine
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C0430370
Descripción
Nitrates Urine
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0028125
Descripción
Bilirubin Urine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0042040
Descripción
Blood Urine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0430372
Descripción
Urobilinogen Urine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0427736
Descripción
Leucocytes Urine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1256582
Descripción
Urinalysis (Microscopy) Test
Alias
- UMLS CUI-1
- C0430397
Descripción
Sedimentary microscopy should only be performed if the dipstick result for protein, nitrates, blood or leucocytes is abnormal.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Descripción
Urinalysis Microscopy - White blood cells
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0023508
Descripción
Urinalysis Microscopy - Red blood cells
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0014772
Descripción
Urinalysis Microspocy - Hyaline casts
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1254537
Descripción
Urinalysis Microscopy - Granular casts
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2697521
Descripción
Urinalysis Microscopy - Cellular casts
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2699157
Similar models
Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)
C0008000 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0549177 (UMLS CUI [1,2])
C0007584 (UMLS CUI [1,3])
C0430370 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0430370 (UMLS CUI [1,2])
C0028125 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,2])
C1254537 (UMLS CUI [1,2])
C2697521 (UMLS CUI [1,2])
C2699157 (UMLS CUI [1,2])