ID
33772
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
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License
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Period 2 Day 1 + Day 5
- StudyEvent: ODM
Description
Day 1
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
integer
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
float
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
Hematology Test
Description
Chemistry
Description
UA / UDS / Urine HCG / Urine Chemistry
Description
Pharmacodynamic Blood Collection
Description
Hormone
Data type
text
Description
not done/not collected
Data type
boolean
Description
Timepoint
Data type
text
Description
Sample Date
Data type
date
Description
Sample Time
Data type
time
Description
Comment
Data type
text
Description
Pharmacodynamic Blood Collection 2
Description
Hormone
Data type
text
Description
not done/not collected?
Data type
boolean
Description
Timepoint
Data type
text
Description
Sample Date
Data type
date
Description
Sample Time
Data type
time
Description
Comment
Data type
text
Description
Day 5
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
Study Drug Administration 2
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., 50
Data type
text
Description
e.g., mg
Data type
text
Description
Site of Injection
Data type
text
Description
Comment
Data type
text
Similar models
Period 2 Day 1 + Day 5
- StudyEvent: ODM