ID

33787

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-12-27 2018-12-27 -
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GSK group of companies

Uppladdad den

27 december 2018

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Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

Engelsk

Period 2 Day 21 + Day 22

1 Formulär  
Administrative data
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Administrative data

Study Site
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Site

Datatyp

text

Subject
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Subject

Datatyp

text

Visit Name
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Visit Name

Datatyp

text

Visit Number
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Visit Number

Datatyp

text

Status
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Status

Datatyp

text

Document Number
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Document Number

Datatyp

integer

Day 21
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Day 21

Visit Date
Beskrivning

Visit Date

Datatyp

date

Vital Signs - Duplicate 1
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Vital Signs - Duplicate 1

Time of Vital Signs
Beskrivning

Time of Vital Signs

Datatyp

time

Blood Pressure - Systolic
Beskrivning

Blood Pressure - Systolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Blood Pressure - Diastolic
Beskrivning

Blood Pressure - Diastolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
°C
Body Position
Beskrivning

e.g., Sitting

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Vital Signs - Duplicate 2
Beskrivning

Vital Signs - Duplicate 2

Time of Vital Signs
Beskrivning

Time of Vital Signs

Datatyp

time

Blood Pressure - Systolic
Beskrivning

Blood Pressure - Systolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Blood Pressure - Diastolic
Beskrivning

Blood Pressure - Diastolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Body Position
Beskrivning

e.g., Sitting

Datatyp

text

Comment
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Comment

Datatyp

text

Study Drug Administration
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Study Drug Administration

Drug Name
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Drug Name

Datatyp

text

Was the dose administered?
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dose administered?

Datatyp

boolean

Dose Date
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Dose Date

Datatyp

date

Dose Time
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Dose Time

Datatyp

time

Dose
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e.g., 0.5 / 0.035

Datatyp

text

Unit
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e.g., mg

Datatyp

text

Comment
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Comment

Datatyp

text

Laboratory Test - Urine HCG
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Laboratory Test - Urine HCG

Timepoint
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Timepoint

Datatyp

text

Was the laboratory sample collected?
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Was the laboratory sample collected?

Datatyp

boolean

Sample Date
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Sample Date

Datatyp

date

Sample Time
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Sample Time

Datatyp

time

Comment
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Comment

Datatyp

text

Pharmacodynamic Blood Collection
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Pharmacodynamic Blood Collection

Hormone
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Hormone

Datatyp

text

Timepoint
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Timepoint

Datatyp

text

Sample Date
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Sample Date

Datatyp

date

Sample Time
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Sample Time

Datatyp

time

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

not done/not collected

Datatyp

boolean

Comment
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Comment

Datatyp

text

Pharmacokinetic Blood Collection
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Pharmacokinetic Blood Collection

Timepoint
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Timepoint

Datatyp

integer

Sample Date
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Sample Date

Datatyp

date

Sample Time
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Sample Time

Datatyp

time

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

not done/not collected

Datatyp

boolean

Comment
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Comment

Datatyp

text

Day 22
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Day 22

Visit Date
Beskrivning

Visit Date

Datatyp

date

Vital Signs - Duplicate 1
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Vital Signs - Duplicate 1

Time of Vital Signs
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Time of Vital Signs

Datatyp

time

Blood Pressure - Systolic
Beskrivning

Blood Pressure - Systolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Blood Pressure - Diastolic
Beskrivning

Blood Pressure - Diastolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
°C
Body Position
Beskrivning

e.g., Sitting

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Vital Signs - Duplicate 2
Beskrivning

Vital Signs - Duplicate 2

Time of Vital Signs
Beskrivning

Time of Vital Signs

Datatyp

time

Blood Pressure - Systolic
Beskrivning

Blood Pressure - Systolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Blood Pressure - Diastolic
Beskrivning

Blood Pressure - Diastolic

Datatyp

float

Måttenheter
  • mmHg
mmHg
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Body Position
Beskrivning

e.g., Sitting

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Study Drug Administration
Beskrivning

Study Drug Administration

Drug Name
Beskrivning

Drug Name

Datatyp

text

Was the dose administered?
Beskrivning

Was the dose administered?

Datatyp

boolean

Dose Date
Beskrivning

Dose Date

Datatyp

date

Dose Time
Beskrivning

Dose Time

Datatyp

time

Dose
Beskrivning

e.g., 0.5 / 0.035

Datatyp

integer

Unit
Beskrivning

e.g., mg

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Pharmacokinetic Blood Collection
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Pharmacokinetic Blood Collection

Timepoint
Beskrivning

Timepoint

Datatyp

text

Sample Date
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Sample Date

Datatyp

date

Sample Time
Beskrivning

Sample Time

Datatyp

time

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

not done/not collected

Datatyp

boolean

Comment
Beskrivning

Comment

Datatyp

text

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1 Formulär
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Datatyp
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Timepoint
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