ID

33728

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)
  1. 12/21/18 12/21/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 21, 2018

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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

English

Run-In Day 1 (Visit 60)

1 forms  
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

Status
Description

Status

Data type

text

Doc №
Description

Doc №

Data type

integer

Is Page Blank?
Description

blank page?

Data type

boolean

UDS / Urine HCG
Description

UDS / Urine HCG

Visit Date
Description

Visit Date

Data type

date

Was the laboratory sample collected?
Description

Was the laboratory sample collected?

Data type

boolean

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

Vital Signs
Description

Vital Signs

Duplicate Number
Description

Duplicate Number

Data type

integer

Date of Vital Signs
Description

Date of Vital Signs

Data type

date

Time
Description

Time

Data type

time

Blood Pressure - Systolic
Description

Blood Pressure - Systolic

Data type

float

Measurement units
  • mmHg
mmHg
Blood Pressure - Diastolic
Description

Blood Pressure - Diastolic

Data type

float

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Body Position
Description

e.g., Sitting

Data type

text

Comment
Description

Comment

Data type

text

Pharmacodynamic Blood Collection
Description

Pharmacodynamic Blood Collection

Timepoint
Description

Timepoint

Data type

text

Sample collected?
Description

Sample collected?

Data type

boolean

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

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Run-In Day 1 (Visit 60)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Visit Name
Code List
Visit Name
CL Item
Run in Day 1 (1)
Status
Item
Status
text
Doc №
Item
Doc №
integer
blank page?
Item
Is Page Blank?
boolean
Item Group
UDS / Urine HCG
Visit Date
Item
Visit Date
date
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
Item Group
Vital Signs
Item
Duplicate Number
integer
Duplicate Number
Code List
Duplicate Number
CL Item
Duplicate 1 (1)
CL Item
Duplicate 2 (2)
Date of Vital Signs
Item
Date of Vital Signs
date
Time
Item
Time
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
Item Group
Pharmacodynamic Blood Collection
Item
Timepoint
text
Timepoint
Code List
Timepoint
CL Item
Pre-dose (1)
Sample collected?
Item
Sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
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