ID
32332
Descripción
This ODM file contains the form to document the physical examination, ecg, vital signs and medical history. To be assessed at screening. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. 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: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia
Palabras clave
Versiones (5)
- 19/10/18 19/10/18 -
- 26/10/18 26/10/18 -
- 26/10/18 26/10/18 -
- 26/10/18 26/10/18 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
26 de octubre de 2018
DOI
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Licencia
Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Medical History, Physical Examination, Vital Signs and ECG (Screening)
Descripción
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Descripción
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0521116
Descripción
PAST MEDICAL CONDITIONS Conditions from which the subject has suffered in the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
Descripción
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Descripción
Hair and skin
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [2]
- C0558035
Descripción
Hair and Skin
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [2]
- C0558035
Descripción
Lymph nodes
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Descripción
Lymph nodes
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Descripción
Eyes
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Descripción
Eyes
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Descripción
Ears, Nose and Throat
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Descripción
Ears, Nose and Throat
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Descripción
Breasts
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Descripción
Breasts
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Descripción
Respiratory
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Descripción
Respiratory
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Descripción
Cardiovascular
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3854344
Descripción
Cardiovascular
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3854344
Descripción
Abdomen
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Descripción
Abdomen
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Descripción
Urogenital
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1828035
Descripción
Urogenital
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1828035
Descripción
Pelvic
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0200045
Descripción
Pelvic
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0200045
Descripción
Rectal
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0199900
Descripción
Rectal
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0199900
Descripción
Musculoskeletal
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0475091
Descripción
Musculoskeletal
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0475091
Descripción
Neurological
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0027853
Descripción
Neurological
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0027853
Descripción
Mental status
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3260990
Descripción
Mental Status
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3260990
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Height
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Blood pressure and heart rate are to be performed after the subject has been in a sitting position for at least 5 minutes followed by standing 1 minute later. Sitting
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descripción
Blood pressure and heart rate are to be performed after the subject has been in a sitting position for at least 5 minutes followed by standing 1 minute later. Sitting
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descripción
Sitting
Tipo de datos
integer
Unidades de medida
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Descripción
ECG
Alias
- UMLS CUI-1
- C1623258
Descripción
In case of clinically significant abnormality: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0438154
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