ID

33787

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. 12/27/18 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

English

Period 2 Day 21 + Day 22

1 forms  
Administrative data
Description

Administrative data

Study Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

Visit Number
Description

Visit Number

Data type

text

Status
Description

Status

Data type

text

Document Number
Description

Document Number

Data type

integer

Day 21
Description

Day 21

Visit Date
Description

Visit Date

Data type

date

Vital Signs - Duplicate 1
Description

Vital Signs - Duplicate 1

Time of Vital Signs
Description

Time of Vital Signs

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

Vital Signs - Duplicate 2
Description

Vital Signs - Duplicate 2

Time of Vital Signs
Description

Time of Vital Signs

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
Body Position
Description

e.g., Sitting

Data type

text

Comment
Description

Comment

Data type

text

Study Drug Administration
Description

Study Drug Administration

Drug Name
Description

Drug Name

Data type

text

Was the dose administered?
Description

dose administered?

Data type

boolean

Dose Date
Description

Dose Date

Data type

date

Dose Time
Description

Dose Time

Data type

time

Dose
Description

e.g., 0.5 / 0.035

Data type

text

Unit
Description

e.g., mg

Data type

text

Comment
Description

Comment

Data type

text

Laboratory Test - Urine HCG
Description

Laboratory Test - Urine HCG

Timepoint
Description

Timepoint

Data type

text

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

Pharmacodynamic Blood Collection
Description

Pharmacodynamic Blood Collection

Hormone
Description

Hormone

Data type

text

Timepoint
Description

Timepoint

Data type

text

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Was the sample collected? / Was the test done?
Description

not done/not collected

Data type

boolean

Comment
Description

Comment

Data type

text

Pharmacokinetic Blood Collection
Description

Pharmacokinetic Blood Collection

Timepoint
Description

Timepoint

Data type

integer

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Was the sample collected? / Was the test done?
Description

not done/not collected

Data type

boolean

Comment
Description

Comment

Data type

text

Day 22
Description

Day 22

Visit Date
Description

Visit Date

Data type

date

Vital Signs - Duplicate 1
Description

Vital Signs - Duplicate 1

Time of Vital Signs
Description

Time of Vital Signs

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

Vital Signs - Duplicate 2
Description

Vital Signs - Duplicate 2

Time of Vital Signs
Description

Time of Vital Signs

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
Body Position
Description

e.g., Sitting

Data type

text

Comment
Description

Comment

Data type

text

Study Drug Administration
Description

Study Drug Administration

Drug Name
Description

Drug Name

Data type

text

Was the dose administered?
Description

Was the dose administered?

Data type

boolean

Dose Date
Description

Dose Date

Data type

date

Dose Time
Description

Dose Time

Data type

time

Dose
Description

e.g., 0.5 / 0.035

Data type

integer

Unit
Description

e.g., mg

Data type

text

Comment
Description

Comment

Data type

text

Pharmacokinetic Blood Collection
Description

Pharmacokinetic Blood Collection

Timepoint
Description

Timepoint

Data type

text

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Was the sample collected? / Was the test done?
Description

not done/not collected

Data type

boolean

Comment
Description

Comment

Data type

text

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Period 2 Day 21 + Day 22

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Study Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Visit Name
Code List
Visit Name
CL Item
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Item
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Visit Number
Code List
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Blood Pressure - Diastolic
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float
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Drug Name
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dose administered?
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Dose Date
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Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
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Sample Date
date
Sample Time
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Sample Time
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Comment
text
Item Group
Pharmacodynamic Blood Collection
Item
Hormone
text
Hormone
Code List
Hormone
CL Item
Progesterone (SP Chem) (1)
Item
Timepoint
text
Timepoint
Code List
Timepoint
CL Item
Predose (1)
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date
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time
not done/not collected
Item
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boolean
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integer
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2.5 hrs (6)
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3 hrs (7)
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4 hrs (8)
CL Item
6 hrs (9)
CL Item
8 hrs (10)
CL Item
10 hrs (11)
CL Item
12 hrs (12)
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Item
Sample Date
date
Sample Time
Item
Sample Time
time
not done/not collected
Item
Was the sample collected? / Was the test done?
boolean
Comment
Item
Comment
text
Item Group
Day 22
Visit Date
Item
Visit Date
date
Item Group
Vital Signs - Duplicate 1
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
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Heart Rate
integer
Temperature
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Temperature
float
Body Position
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Body Position
text
Comment
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Vital Signs - Duplicate 2
Time of Vital Signs
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Time of Vital Signs
time
Blood Pressure - Systolic
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Blood Pressure - Systolic
float
Blood Pressure - Diastolic
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Blood Pressure - Diastolic
float
Heart Rate
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Heart Rate
integer
Body Position
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Body Position
text
Comment
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text
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Study Drug Administration
Item
Drug Name
text
Drug Name
Code List
Drug Name
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
integer
Unit
Item
Unit
text
Comment
Item
Comment
text
Item Group
Pharmacokinetic Blood Collection
Item
Timepoint
text
Timepoint
Code List
Timepoint
CL Item
24 hrs (1)
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
not done/not collected
Item
Was the sample collected? / Was the test done?
boolean
Comment
Item
Comment
text
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