ID

33731

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

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 1 Day 1 (Visit 80)

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

Visit Date
Description

Visit Date

Data type

date

Admission Criteria
Description

Admission Criteria

Protocol Date
Description

Protocol Date

Data type

date

Does the subject continue to meet all eligibility criteria?
Description

Does the subject continue to meet all eligibility criteria?

Data type

boolean

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

text

Unit
Description

e.g., mg

Data type

text

Comment
Description

Comment

Data type

text

Laboratory Test - Hematology
Description

Laboratory Test - Hematology

Was laboratory sample collected?
Description

Was 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

Laboratory Test - Chemistry
Description

Laboratory Test - Chemistry

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

Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry
Description

Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry

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

Date of Vital Signs
Description

Date of Vital Signs

Data type

date

Duplicate Number
Description

Duplicate Number

Data type

integer

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

Was the sample collected?
Description

Was the sample collected?

Data type

boolean

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

Comment
Description

Comment

Data type

text

Pharmacodynamic Blood Collection
Description

Pharmacodynamic Blood Collection

Was the sample collected?
Description

Was the sample collected?

Data type

boolean

Hormone
Description

Hormone

Data type

text

Timepoint
Description

Timepoint

Data type

text

Sample Date
Description

Sample Date

Data type

time

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

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Similar models

Period 1 Day 1 (Visit 80)

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
Period 1 Day 1 (1)
Status
Item
Status
text
Doc №
Item
Doc №
integer
blank page?
Item
Is Page Blank?
boolean
Visit Date
Item
Visit Date
date
Item Group
Admission Criteria
Protocol Date
Item
Protocol Date
date
Does the subject continue to meet all eligibility criteria?
Item
Does the subject continue to meet all eligibility criteria?
boolean
Item Group
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
text
Unit
Item
Unit
text
Comment
Item
Comment
text
Item Group
Laboratory Test - Hematology
Was laboratory sample collected?
Item
Was laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Laboratory Test - Chemistry
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
Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry
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
Date of Vital Signs
Item
Date of Vital Signs
date
Item
Duplicate Number
integer
Duplicate Number
Code List
Duplicate Number
CL Item
Duplicate 1 (1)
CL Item
Duplicate 2 (2)
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
Was the sample collected?
Item
Was the sample collected?
boolean
Item
Hormone
text
Hormone
Code List
Hormone
CL Item
Progesterone (SP Chem) (1)
Item
Timepoint
text
Timepoint
Code List
Timepoint
CL Item
Pre-dose (1)
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Pharmacodynamic Blood Collection
Was the sample collected?
Item
Was the sample collected?
boolean
Item
Hormone
text
Hormone
Code List
Hormone
CL Item
LH / FSH (SP Chemistry) (1)
Item
Timepoint
text
Timepoint
Code List
Timepoint
CL Item
Pre-dose (1)
Sample Date
Item
Sample Date
time
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
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