ID

32736

Description

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Keywords

Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

English

Pharmacokinetics

1 forms  
  1. StudyEvent: ODM
    1. Pharmacokinetics
Pharmacokinetics
Description

Pharmacokinetics

Alias
UMLS CUI-1
C0031328
Was a pharmacokinetic blood sample obtained?
Description

Pharmacokinetic aspects, Blood, Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
Date and time sample taken
Description

Pharmacokinetic aspects, Blood, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Date and time of last investigational product dose prior to PK sample
Description

Pharmacokinetic aspects, Blood, Experimental drug, Date last dose, Time last dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1762893
UMLS CUI [1,5]
C0946444
Sample Identifier
Description

Pharmacokinetic aspects, Blood, Sample Identification Number

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
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Similar models

Pharmacokinetics

1 forms
  1. StudyEvent: ODM
    1. Pharmacokinetics
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pharmacokinetics
C0031328 (UMLS CUI-1)
Pharmacokinetic aspects, Blood, Sampling
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Pharmacokinetic aspects, Blood, Experimental drug, Date last dose, Time last dose
Item
Date and time of last investigational product dose prior to PK sample
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,4])
C0946444 (UMLS CUI [1,5])
Pharmacokinetic aspects, Blood, Sample Identification Number
Item
Sample Identifier
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
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