Information:
Fel:
ID
33755
Beskrivning
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2
Nyckelord
Versioner (1)
- 2018-12-24 2018-12-24 -
Rättsinnehavare
GSK group of companies
Uppladdad den
24 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Period 1 Day 20-21 (Visit 140-150): Vital Signs, Drug Administration, ECG, Laboratory Tests
Similar models
Period 1 Day 20-21 (Visit 140-150): Vital Signs, Drug Administration, ECG, Laboratory Tests
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Period 1 Day 20 (1)
Status
Item
Status
text
Document #
Item
Document #
text
Visit Date
Item
Visit Date
date
Date of Vital Signs
Item
Date of Vital Signs
date
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
CL Item
Brevicon (1)
Was the dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Dose
Item
Dose
text
Unit
Item
Unit
text
Comment
Item
Comment
text
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
CL Item
Day 20 (1)
Comment
Item
Comment
text
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
CL Item
Predose (1)
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
sample collected?
Item
Was the sample collected?
boolean
Comment
Item
Comment
text
Date of Visit
Item
Date of Visit
date
Date of Vital Signs
Item
Date of Vital Signs
date
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Date ECG Performed
Item
Date ECG Performed
date
Time ECG performed
Item
Time ECG performed
time
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
float
QRS Duration
Item
QRS Duration
float
QT Interval
Item
QT Interval
float
QTcB Interval
Item
QTcB Interval
float
QTcF Interval
Item
QTcF Interval
float
RR Interval
Item
RR Interval
float
Normal Sinus Rhythm?
Item
Normal Sinus Rhythm?
boolean
CL Item
Normal (1)
CL Item
Abnormal; Not Clinically Significant (2)
CL Item
Abnormal; Clinically Significant (3)
If Abnormal, please specify:
Item
If Abnormal, please specify:
text
CL Item
Brevicon (1)
Was the dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Dose
Item
Dose
text
Unit
Item
Unit
text
Comment
Item
Comment
text
CL Item
Progesterone (SP Chem) (1)
CL Item
Predose (1)
Date sample taken
Item
Date sample taken
date
Time sample taken
Item
Time sample taken
time
Was the sample collected?
Item
Was the sample collected?
boolean
Comment
Item
Comment
text
CL Item
Predose (1)
CL Item
0.5 hr (2)
CL Item
1 hr (3)
CL Item
1.5 hrs (4)
CL Item
2 hrs (5)
CL Item
2.5 hrs (6)
CL Item
3 hrs (7)
CL Item
4 hrs (8)
CL Item
6 hrs (9)
CL Item
8 hrs (10)
CL Item
10 hrs (11)
CL Item
12 hrs (12)
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Was the sample collected / Was the test done?
Item
Was the sample collected / Was the test done?
boolean
Comment
Item
Comment
text