ID

29504

Description

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Concomitant Medications

Mots-clés

Versions (1)
  1. 04/04/2018 04/04/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

4 avril 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

Anglais

Concomitant Medications

1 Formulaires  
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Were any concomitant medications taken by the subject within 7 days prior to dosing and/or during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
Drug Name
Description

Drug Name

Type de données

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Dose
Description

Dose

Type de données

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Unit
Description

Unit

Type de données

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Description

Frequency

Type de données

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Description

Route

Type de données

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Description

Reason for Medication

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0392360
Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Start Time
Description

Start Time

Type de données

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken Prior to Study?
Description

Taken Prior to Study?

Type de données

boolean

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

Stop Date

Type de données

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
Stop time
Description

Stop time

Type de données

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
Ongoing Medication?
Description

Ongoing Medication?

Type de données

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medications

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Concomitant medications
Item
Were any concomitant medications taken by the subject within 7 days prior to dosing and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Unit
Code List
Unit
CL Item
Tablet  (TAB)
CL Item
Microlitre  (MCL)
CL Item
Millilitre  (ML)
CL Item
Litre  (L)
CL Item
Microgram  (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intramuscular (1)
(Comment:en)
CL Item
Inhalation (2)
(Comment:en)
CL Item
Intravenous (3)
(Comment:en)
CL Item
Nasal (4)
(Comment:en)
CL Item
Topical (5)
(Comment:en)
CL Item
Oral (6)
(Comment:en)
CL Item
Vaginal (7)
(Comment:en)
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop time
Item
Stop time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
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