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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 2: Regimen

- 13/12/18 - 1 modulo, 2 itemgroups, 4 elementi, 1 linguaggio
Itemgroups: 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 - Session 2: Investigational Product

- 13/12/18 - 1 modulo, 5 itemgroups, 19 elementi, 1 linguaggio
Itemgroups: 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: Investigational Product

- 11/12/18 - 1 modulo, 5 itemgroups, 19 elementi, 1 linguaggio
Itemgroups: 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 3: Investigational Product

- 09/01/19 - 1 modulo, 5 itemgroups, 19 elementi, 1 linguaggio
Itemgroups: 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

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Session 1-4: Vital Signs; Pharmacokinetics Blood; Investigational Product; Treatment Confirmation; 12-Lead ECG

- 10/05/21 - 1 modulo, 17 itemgroups, 57 elementi, 1 linguaggio
Itemgroups: Administrative, Date of Visit/ Assessment, Randomisation (only Session 1), Vital Signs, Sitting Vital Signs - Predose, Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins , Orthostatic Vital Signs - Post Dose - Sitting, Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins , Pharmacokinetics Blood - Dosing Date and Time, Pharmacokinetics Blood, Investigational Product, Treatment Confirmation, 12-Lead ECG (only Session 4)
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 3: Regimen

- 13/12/18 - 1 modulo, 2 itemgroups, 4 elementi, 1 linguaggio
Itemgroups: 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

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Investigational Product Dosing, Randomisation

- 11/10/19 - 1 modulo, 3 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Administrative Data, Randomisation, Investigational Product
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Investigational Product - IV Dosing and the Randomisation form. It has to be filled in for Day 1 and Week 2.

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Concomitant Medications

- 11/01/19 - 1 modulo, 2 itemgroups, 17 elementi, 1 linguaggio
Itemgroups: Administrative data, Concomitant Medications
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 4: Investigational Product

- 09/01/19 - 1 modulo, 5 itemgroups, 20 elementi, 1 linguaggio
Itemgroups: 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 4: Regimen

- 13/12/18 - 1 modulo, 2 itemgroups, 4 elementi, 1 linguaggio
Itemgroups: 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 - Logs and Repeats: Adverse Event

- 11/01/19 - 1 modulo, 2 itemgroups, 21 elementi, 1 linguaggio
Itemgroups: Administrative data, Adverse Events
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 - Pregnancy Notification Form

- 11/01/19 - 1 modulo, 7 itemgroups, 46 elementi, 1 linguaggio
Itemgroups: Administrative data, Pregnancy Notification Form (Subject), Mother's Relevant Medical/Family History, If applicable, record the number in the appropriate categories below:, Father's Relevant Medical/Family History, Drug Exposures, Reporting Investigator Information
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

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