ID
35645
Beskrivning
Study ID: 103268 Clinical Study ID: 103268 Study Title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00536679 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK163090 capsule, fasted/fed Trade Name: N/A Study Indication: Depression; Depressive Disorder and Anxiety Disorders
Nyckelord
Versioner (1)
- 2019-03-13 2019-03-13 -
Rättsinnehavare
GSK group of companies
Uppladdad den
13 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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the Effect of Food on the Pharmacokinetics of a Tablet Formulation - 103268
Pregnancy Report
- StudyEvent: ODM
Beskrivning
Pregnancy Notification Form
Alias
- UMLS CUI-1
- C0032961
Beskrivning
Subject Identifier
Datatyp
text
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Mothers date of birth
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0421451
Beskrivning
Date of last menstrual period
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0025329
Beskrivning
Estimated date of delivery
Datatyp
date
Alias
- UMLS CUI [1]
- C1287845
Beskrivning
contraception
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
Was the mother using a method of contraception?
Datatyp
text
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
Type of conception
Datatyp
integer
Alias
- UMLS CUI [1]
- C2598844
Beskrivning
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beskrivning
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatyp
text
Alias
- UMLS CUI [1]
- C0430022
Beskrivning
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0011008
Beskrivning
Pre-term pregnancies
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1547235
- UMLS CUI [1,3]
- C0449788
Beskrivning
Full-term pregnancy
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2114495
- UMLS CUI [1,2]
- C0449788
Beskrivning
Normal births
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beskrivning
Stillbirths
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0595939
- UMLS CUI [1,2]
- C0449788
Beskrivning
Children born with defects
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0449788
Beskrivning
Children born with defects
Datatyp
text
Alias
- UMLS CUI [1]
- C0000768
Beskrivning
Spontaneous abortion
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beskrivning
Elective abortion
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0269439
- UMLS CUI [1,2]
- C0449788
Beskrivning
other birth
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005615
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449788
Beskrivning
impact on the outcome of this pregnancy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beskrivning
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beskrivning
Fathers relevant medical/family history
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2]
- C0241889
Beskrivning
withdrawn from the study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0032961
Beskrivning
Drug Exposures
Alias
- UMLS CUI-1
- C0743284
Beskrivning
Trade Name preferred
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Route of Admin. or Formulation
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Total Daily Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Started Pre-Study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beskrivning
Start Date
Datatyp
date
Måttenheter
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Stop Date
Datatyp
date
Måttenheter
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Ongoing Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
REPORTING INVESTIGATOR INFORMATION
Alias
- UMLS CUI-1
- C1955348
- UMLS CUI-2
- C0008961
Beskrivning
Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0008961
Beskrivning
Title
Datatyp
text
Alias
- UMLS CUI [1]
- C3888414
Beskrivning
Speciality
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037778
- UMLS CUI [1,2]
- C0008961
Beskrivning
Address
Datatyp
text
Alias
- UMLS CUI [1]
- C1442065
Beskrivning
City
Datatyp
text
Alias
- UMLS CUI [1]
- C0008848
Beskrivning
Country
Datatyp
text
Alias
- UMLS CUI [1]
- C0454664
Beskrivning
Zip Code
Datatyp
integer
Alias
- UMLS CUI [1]
- C0421454
Beskrivning
Telephone No
Datatyp
integer
Alias
- UMLS CUI [1]
- C1515258
Beskrivning
Fax No
Datatyp
integer
Alias
- UMLS CUI [1]
- C1549619
Beskrivning
Investigator signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
Pregnancy Report
- StudyEvent: ODM
C0421451 (UMLS CUI [1,2])
C0025329 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1547235 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C1521761 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2])
C0032961 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0008961 (UMLS CUI-2)
C0008961 (UMLS CUI [1,2])