ID

38820

Beskrivning

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Nyckelord

Versioner (1)
  1. 2019-11-06 2019-11-06 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 november 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

Engelsk

Pharmacokinetics Blood (Period 1 - 5; Day 1 - Day 16)

1 Formulär  
Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)
Beskrivning

Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0178602
UMLS CUI-4
C1264639
Dosing date and time
Beskrivning

Dosing date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Repeat Pharmacokinetics Blood (Period 1 - 5)
Beskrivning

Repeat Pharmacokinetics Blood (Period 1 - 5)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0205341
Actual date/time
Beskrivning

Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1]
C1264639
Timepoint
Beskrivning

Timepoint

Datatyp

integer

Alias
UMLS CUI [1]
C2348792
Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)
Beskrivning

Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
AM Dosing date and time
Beskrivning

AM Dosing date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C4331833
PM Dosing date and time
Beskrivning

PM Dosing date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Pharmacokinetics Blood (Day 1 - 13)
Beskrivning

Pharmacokinetics Blood (Day 1 - 13)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Timepoint
Beskrivning

Timepoint

Datatyp

integer

Alias
UMLS CUI [1]
C2348792
Actual date/time
Beskrivning

Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1]
C1264639
Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)
Beskrivning

Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
AM Dosing date and time
Beskrivning

AM Dosing date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
PM Dosing date and time
Beskrivning

PM Dosing date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Pharmacokinetics Blood (Day 14 - 16)
Beskrivning

Pharmacokinetics Blood (Day 14 - 16)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Timepoint
Beskrivning

Timepoint

Datatyp

integer

Alias
UMLS CUI [1]
C2348792
Actual date/time
Beskrivning

Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1]
C1264639
Tillbaka till toppen

Similar models

Pharmacokinetics Blood (Period 1 - 5; Day 1 - Day 16)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Repeat Pharmacokinetics Blood (Period 1 - 5)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Pre dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
24 hr (9)
Item Group
Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
AM Dosing date and time
Item
AM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
PM Dosing date and time
Item
PM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Pharmacokinetics Blood (Day 1 - 13)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Pre dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
12 hr:15 mins (9)
CL Item
12 hr: 30 mins (10)
CL Item
13 hr (11)
CL Item
14 hr (12)
CL Item
16 hr (13)
CL Item
20 hr (14)
CL Item
24 hr (15)
CL Item
36 hr (16)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Item Group
Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
AM Dosing date and time
Item
AM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
PM Dosing date and time
Item
PM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Pharmacokinetics Blood (Day 14 - 16)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Pre dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
12 hr:15 mins (9)
CL Item
12 hr:30 mins (10)
CL Item
13 hr (11)
CL Item
14 hr (12)
CL Item
16 hr (13)
CL Item
20 hr (14)
CL Item
24 hr (15)
CL Item
36 hr (16)
CL Item
48 hr (17)
CL Item
60 hr (18)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial