ID

34175

Description

This ODM file contains a form for the documention required at the 0.5 - 72 hours timepoints. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Keywords

Versions (5)
  1. 10/21/18 10/21/18 -
  2. 10/21/18 10/21/18 -
  3. 10/26/18 10/26/18 -
  4. 10/29/18 10/29/18 -
  5. 1/15/19 1/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880

English

0.5 - 72 Hour Timepoints Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Period
Description

Study Period

Data type

integer

Alias
UMLS CUI [1]
C2347804
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Planned Relative Time
Description

Time Relative to Dosing In brackets, the sample number according to the planned relative time is given; the first number indicates the period.

Data type

text

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Description

Date Sample Taken

Data type

date

Alias
UMLS CUI [1]
C1302413
If sample is missed or lost, write "NA" here instead of a date in the Date Sample Taken column.
Description

Date sample taken not applicable because sample missed or lost

Data type

text

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C1272460
Actual Time
Description

Actual Time

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1]
C0040223
Hr : Min
3mL Sample Taken
Description

3mL Sample Taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Vital signs: Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Description

Vital signs: Planned relative time

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Description

Vital signs: Actual time

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1]
C2826762
Hr : Min
Blood pressure (Sitting) (Systolic)
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (Sitting) (Diastolic)
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
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Similar models

0.5 - 72 Hour Timepoints Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
Study Period
integer
C2347804 (UMLS CUI [1])
Visit Type
Code List
Study Period
CL Item
Period 1 (1)
CL Item
Period 2 (2)
CL Item
Period 3 (3)
Item Group
Pharmacokinetics - Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Planned Relative Time of Dosage
Code List
Planned Relative Time
CL Item
0.5 hour (101, 201, 301) (1.)
CL Item
1 hour (102, 202, 302) (2.)
CL Item
2 hours (103, 203, 303) (3.)
CL Item
3 hours (104, 204, 304) (4.)
CL Item
4 hours (105, 205, 305) (5.)
CL Item
6 hours (106, 206, 306) (6.)
CL Item
8 hours (107, 207, 307) (7.)
CL Item
12 hours (108, 208, 308) (8.)
CL Item
24 hours (109, 209, 309) (9.)
CL Item
36 hours (110, 210, 310) (10.)
CL Item
48 hours (111, 211, 311) (11.)
CL Item
72 hours (112, 212, 312) (12.)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Date sample taken not applicable because sample missed or lost
Item
If sample is missed or lost, write "NA" here instead of a date in the Date Sample Taken column.
text
C1302413 (UMLS CUI [1,1])
C1272460 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
3mL Sample Taken
Item
3mL Sample Taken
boolean
C1277698 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital signs: Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Vital signs: planned relative time
Code List
Planned Relative Time
CL Item
2 hour (2 hour)
CL Item
24 hour (24 hour)
CL Item
36 hour (36 hour)
CL Item
48 hour (48 hour)
CL Item
72 hour (72 hour)
Vital signs: Actual time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic blood pressure
Item
Blood pressure (Sitting) (Systolic)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure (Sitting) (Diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
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