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