ID
32128
Beschreibung
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
Stichworte
Versionen (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 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
19. Oktober 2018
DOI
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Lizenz
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)
Beschreibung
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschreibung
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0521116
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Hair and skin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Beschreibung
Hair and Skin
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Beschreibung
Lymph nodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beschreibung
Lymph nodes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beschreibung
Eyes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Beschreibung
Eyes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Beschreibung
Ears, Nose and Throat
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Beschreibung
Ears, Nose and Throat
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Beschreibung
Breasts
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Beschreibung
Breasts
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Beschreibung
Respiratory
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Beschreibung
Respiratory
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Beschreibung
Cardiovascular
Datentyp
integer
Alias
- UMLS CUI [1]
- C3854344
Beschreibung
Cardiovascular
Datentyp
text
Alias
- UMLS CUI [1]
- C3854344
Beschreibung
Abdomen
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschreibung
Abdomen
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschreibung
Urogenital
Datentyp
integer
Alias
- UMLS CUI [1]
- C1828035
Beschreibung
Urogenital
Datentyp
text
Alias
- UMLS CUI [1]
- C1828035
Beschreibung
Pelvic
Datentyp
integer
Alias
- UMLS CUI [1]
- C0200045
Beschreibung
Pelvic
Datentyp
text
Alias
- UMLS CUI [1]
- C0200045
Beschreibung
Rectal
Datentyp
integer
Alias
- UMLS CUI [1]
- C0199900
Beschreibung
Rectal
Datentyp
text
Alias
- UMLS CUI [1]
- C0199900
Beschreibung
Musculoskeletal
Datentyp
integer
Alias
- UMLS CUI [1]
- C0475091
Beschreibung
Musculoskeletal
Datentyp
text
Alias
- UMLS CUI [1]
- C0475091
Beschreibung
Neurological
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Neurological
Datentyp
text
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Mental status
Datentyp
integer
Alias
- UMLS CUI [1]
- C3260990
Beschreibung
Mental Status
Datentyp
text
Alias
- UMLS CUI [1]
- C3260990
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
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
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
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
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Sitting
Datentyp
integer
Maßeinheiten
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
ECG
Alias
- UMLS CUI-1
- C1623258
Ähnliche Modelle
Medical History, Physical Examination, Vital Signs and ECG (Screening)
C0521116 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
C0200149 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
C0199850 (UMLS CUI [1,2])
C0599324 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])