ID
35645
Beschrijving
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
Trefwoorden
Versies (1)
- 13-03-19 13-03-19 -
Houder van rechten
GSK group of companies
Geüploaded op
13 maart 2019
DOI
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Licentie
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
Beschrijving
Pregnancy Notification Form
Alias
- UMLS CUI-1
- C0032961
Beschrijving
Subject Identifier
Datatype
text
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Mothers date of birth
Datatype
date
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0421451
Beschrijving
Date of last menstrual period
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0025329
Beschrijving
Estimated date of delivery
Datatype
date
Alias
- UMLS CUI [1]
- C1287845
Beschrijving
contraception
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Was the mother using a method of contraception?
Datatype
text
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Type of conception
Datatype
integer
Alias
- UMLS CUI [1]
- C2598844
Beschrijving
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschrijving
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatype
text
Alias
- UMLS CUI [1]
- C0430022
Beschrijving
Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pre-term pregnancies
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1547235
- UMLS CUI [1,3]
- C0449788
Beschrijving
Full-term pregnancy
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2114495
- UMLS CUI [1,2]
- C0449788
Beschrijving
Normal births
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beschrijving
Stillbirths
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0595939
- UMLS CUI [1,2]
- C0449788
Beschrijving
Children born with defects
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0449788
Beschrijving
Children born with defects
Datatype
text
Alias
- UMLS CUI [1]
- C0000768
Beschrijving
Spontaneous abortion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beschrijving
Elective abortion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0269439
- UMLS CUI [1,2]
- C0449788
Beschrijving
other birth
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005615
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449788
Beschrijving
impact on the outcome of this pregnancy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beschrijving
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beschrijving
Fathers relevant medical/family history
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2]
- C0241889
Beschrijving
withdrawn from the study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0032961
Beschrijving
Drug Exposures
Alias
- UMLS CUI-1
- C0743284
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Route of Admin. or Formulation
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Total Daily Dose
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Started Pre-Study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beschrijving
Start Date
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Stop Date
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Ongoing Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
REPORTING INVESTIGATOR INFORMATION
Alias
- UMLS CUI-1
- C1955348
- UMLS CUI-2
- C0008961
Beschrijving
Name
Datatype
text
Alias
- UMLS CUI [1]
- C0008961
Beschrijving
Title
Datatype
text
Alias
- UMLS CUI [1]
- C3888414
Beschrijving
Speciality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037778
- UMLS CUI [1,2]
- C0008961
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1]
- C1442065
Beschrijving
City
Datatype
text
Alias
- UMLS CUI [1]
- C0008848
Beschrijving
Country
Datatype
text
Alias
- UMLS CUI [1]
- C0454664
Beschrijving
Zip Code
Datatype
integer
Alias
- UMLS CUI [1]
- C0421454
Beschrijving
Telephone No
Datatype
integer
Alias
- UMLS CUI [1]
- C1515258
Beschrijving
Fax No
Datatype
integer
Alias
- UMLS CUI [1]
- C1549619
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date
Datatype
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])