ID
38074
Beschrijving
Two-Part Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Oral Dosesof the Enteric-Coated Free Base Formulation of Darapladib (SB-480848) ina Dose Rising Fashion and to Evaluate the Safety, Tolerability and Pharmacokinetics of Darapladib when Co-administered with Ketoconazole in Healthy Adult Subjects. There are 4 parts to this study: Screening, Part A, Part B, and Follow-Up. Part A contains 2 Sessions per day for day 1-10, Part B contains 1 Session per day for day 1-14. Each itemgroup contains information when it should be filled out. The itemgroups of the non-serious and serious adverse event forms contain additional information on the definition of a serious/non-serious adverse event.
Trefwoorden
Versies (1)
- 15-09-19 15-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 september 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988
Vital Signs
Beschrijving
Vital Parameters Screening
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Visit Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Planned relative time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301732
- UMLS CUI [1,2]
- C0439564
Beschrijving
Actual Time - Start
Datatype
time
Alias
- UMLS CUI [1,1]
- C0237400
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439659
Beschrijving
Actual Time - Stop
Datatype
time
Alias
- UMLS CUI [1,1]
- C0237400
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0444930
Beschrijving
Blood Pressure Supine - Systolic
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0039155
Beschrijving
Blood Pressure Supine - Diastolic
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0012000
Beschrijving
Heart Rate
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Similar models
Vital Signs
C0439564 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0039155 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0012000 (UMLS CUI [1,3])