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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 2: Date of Visit/Assessment

- 13.12.18 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: Administrative data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Vital Signs Form

- 13.12.18 - 1 Formular, 23 Itemgruppen, 89 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Pharmacokinetics Blood

- 13.12.18 - 1 Formular, 20 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dosing Date and Time, Predose, 30 Minutes, 45 Minutes, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 5 Hours, 6 Hours, 7 Hours, 8 Hours, 10 Hours, 12 Hours, 18 Hours, 24 Hours, 32 Hours, 48 Hours
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Investigational Product

- 11.12.18 - 1 Formular, 5 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Investigational Product - Regimen A - 40 mg Carvedilol CR, Investigational Product - 40 mg Carvedilol Regimen B Alcohol Ingestion - 240 ml OF 20%EtOH, Investigational Product - Regimen C Alcohol Ingestion - 240 ml OF 20% EtOH, Investigational Product - Regimen D Alcohol Ingestion - 240 ml OF 20% EtOH
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Treatment Confirmation

- 11.12.18 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Treatment Confirmation Question
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Randomisation Number Form

- 11.12.18 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Randomisation Number
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Regimen

- 11.12.18 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Regimen
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Subject Identification

- 11.12.18 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: Administrative data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Date of Visit/Assessment

- 11.12.18 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: Administrative data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Date of Visit

- 11.12.18 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: Administrative data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Pharmacokinetics (Liver PK)

- 07.12.18 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache
Itemgruppe: An unscheduled PK sample must be obtained within 24 hours of last dose
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Pharmacokinetics(cold analysis, metabolites, plasma radioactivity, sampling urine interval collection data, sampling faeces interval collection data)

- 04.12.18 - 1 Formular, 6 Itemgruppen, 32 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pharmacokinetics - Blood, Pharmacokinetics - Blood (metabolites), Pharmacokinetics - Blood (plasma radioactivity), Pharmacokinetics sampling urine interval collection data, Pharmacokinetics sampling faeces interval collection data
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the Pharmacokinetics - Blood form (cold analysis, metabolites, plasma radioactivity, sampling urine interval collection data, sampling faeces interval collection data). It has to be filled in for study visit.

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