ID
33784
Description
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
Keywords
Versions (1)
- 12/27/18 12/27/18 -
Copyright Holder
GSK group of companies
Uploaded on
December 27, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Period 2 Day 18 + Day 19 + Day 20
- StudyEvent: ODM
Description
Day 18
Description
Vital Signs - Duplicate 1
Description
Time of Vital Signs
Data type
time
Description
Blood Pressure - Systolic
Data type
float
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
float
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Temperature
Data type
float
Measurement units
- °C
Description
e.g., Sitting
Data type
text
Description
Comment
Data type
text
Description
Vital Signs - Duplicate 2
Description
Time of Vital Signs
Data type
time
Description
Blood Pressure - Systolic
Data type
float
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
float
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
e.g., Sitting
Data type
text
Description
Comment
Data type
text
Description
Study Drug Administration
Description
Drug Name
Data type
text
Description
dose administered?
Data type
boolean
Description
Dose Date
Data type
date
Description
Dose Time
Data type
time
Description
e.g., 0.5 / 0.035
Data type
text
Description
e.g., mg
Data type
text
Description
Comment
Data type
text
Description
Day 19
Description
Vital Signs - Duplicate 1
Description
Time of Vital Signs
Data type
time
Description
Blood Pressure - Systolic
Data type
float
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
float
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Temperature
Data type
float
Measurement units
- °C
Description
e.g., Sitting
Data type
text
Description
Comment
Data type
text
Description
Vital Signs - Duplicate 2
Description
Time of Vital Signs
Data type
time
Description
Blood Pressure - Systolic
Data type
float
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
float
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
e.g., Sitting
Data type
text
Description
Comment
Data type
text
Description
Study Drug Administration
Description
Drug Name
Data type
text
Description
Was the dose administered?
Data type
boolean
Description
Dose Date
Data type
date
Description
Dose Time
Data type
time
Description
e.g., 0.5 / 0.035
Data type
text
Description
e.g., mg
Data type
text
Description
Comment
Data type
text
Description
Study Drug Administration 2
Description
Drug Name
Data type
text
Description
Was the dose administered?
Data type
boolean
Description
Dose Date
Data type
date
Description
Dose Time
Data type
time
Description
e.g., 50
Data type
text
Description
e.g., mg
Data type
text
Description
Site of Injection
Data type
text
Description
Comment
Data type
text
Description
Pharmacokinetic Blood Collection
Description
Day 20
Description
Vital Signs - Duplicate 1
Description
Time of Vital Signs
Data type
time
Description
Blood Pressure - Systolic
Data type
float
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
float
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Temperature
Data type
float
Measurement units
- °C
Description
e.g., Sitting
Data type
text
Description
Comment
Data type
text
Description
Vital Signs - Duplicate 2
Description
Time of Vital Signs
Data type
time
Description
Blood Pressure - Systolic
Data type
float
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
float
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
e.g., Sitting
Data type
text
Description
Comment
Data type
text
Description
Electrocardiogram
Description
Date of ECG performed
Data type
date
Description
Time of ECG performed
Data type
time
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
PR Interval
Data type
float
Measurement units
- msec
Description
QRS Duration
Data type
float
Measurement units
- msec
Description
QT Interval
Data type
float
Measurement units
- msec
Description
QTcB Interval
Data type
float
Measurement units
- msec
Description
QTcF Interval
Data type
float
Measurement units
- msec
Description
RR Interval
Data type
float
Measurement units
- msec
Description
Normal Sinus Rhythm?
Data type
boolean
Description
Overall Interpretation of ECG
Description
Study Drug Administration
Description
Drug Name
Data type
text
Description
dose administered?
Data type
boolean
Description
Dose Date
Data type
date
Description
Dose Time
Data type
time
Description
e.g., 0.5 / 0.035
Data type
text
Description
e.g., mg
Data type
text
Description
Comment
Data type
text
Description
Hematologic Test
Description
Chemistry Test
Description
UA/Urine Chemistry
Description
Pharmacokinetic Blood Collection
Similar models
Period 2 Day 18 + Day 19 + Day 20
- StudyEvent: ODM