Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Vital Signs Form

- 11/01/2019 - 1 Formulaire, 2 Groupes Item, 11 Eléments de données, 1 Langue

Groupes Item: Administrative data, Vital Signs

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: Vital Signs Form

- 09/01/2019 - 1 Formulaire, 23 Groupes Item, 89 Eléments de données, 1 Langue

Groupes Item: 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Unscheduled Visit: Vital Signs, Physical Examination,

- 28/12/2018 - 1 Formulaire, 14 Groupes Item, 69 Eléments de données, 1 Langue

Groupes Item: Administrative data, Vital Signs, Blood Pressure, Heart Rate, Respiratory Rate, Temperature, Physical Examination, Assessment, Electrocardiogram, ECG Details, Overall Interpretation of ECG, Central Laboratory Tests, Blood, Urine

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Early Term Data: Vital Signs, Physical Examination, ECG, Laboratory Tests

- 28/12/2018 - 1 Formulaire, 9 Groupes Item, 55 Eléments de données, 1 Langue

Groupes Item: Administrative data, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Physical Examination, Electrocardiogram, Overall Interpretation of ECG, Hematologic Test, Chemistry Test, UA / Urine Chemistry Test

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 21 + Day 22

- 27/12/2018 - 1 Formulaire, 13 Groupes Item, 69 Eléments de données, 1 Langue

Groupes Item: Administrative data, Day 21, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Laboratory Test - Urine HCG, Pharmacodynamic Blood Collection, Pharmacokinetic Blood Collection, Day 22, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 18 + Day 19 + Day 20

- 27/12/2018 - 1 Formulaire, 21 Groupes Item, 112 Eléments de données, 1 Langue

Groupes Item: Administrative data, Day 18, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Day 19, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2 , Pharmacokinetic Blood Collection, Day 20, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Hematologic Test, Chemistry Test, UA/Urine Chemistry, Pharmacokinetic Blood Collection

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 13 + Day 14

- 27/12/2018 - 1 Formulaire, 13 Groupes Item, 72 Eléments de données, 1 Langue

Groupes Item: Administrative data, Day 13, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacodynamic Blood Collection, Day 14, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Pharmacodynamic Blood Collection

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 11 + Day 12

- 27/12/2018 - 1 Formulaire, 12 Groupes Item, 68 Eléments de données, 1 Langue

Groupes Item: Administrative data, Day 11, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacodynamic Blood Collection, Day 12, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2 , Pharmacodynamic Blood Collection

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 1 + Day 5

- 27/12/2018 - 1 Formulaire, 15 Groupes Item, 80 Eléments de données, 1 Langue

Groupes Item: Administrative data, Day 1, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Hematology Test, Chemistry, UA / UDS / Urine HCG / Urine Chemistry, Pharmacodynamic Blood Collection, Pharmacodynamic Blood Collection 2, Day 5, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 22+26 (Visit 160-170): Vital Signs, Drug Administration, ECG, Laboratory Tests

- 24/12/2018 - 1 Formulaire, 11 Groupes Item, 57 Eléments de données, 1 Langue

Groupes Item: Administrative data, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection, Period 1 - Day 26, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 20-21 (Visit 140-150): Vital Signs, Drug Administration, ECG, Laboratory Tests

- 24/12/2018 - 1 Formulaire, 18 Groupes Item, 91 Eléments de données, 1 Langue

Groupes Item: Administrative data, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration, Hematology Test, Chemistry Test, UA / Urine Chemistry Test, Pharmacokinetic Blood Collection, Period 1 - Day 21, Vital Signs, Duplicate 1, Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Pharmacodynamic Blood Connection, Pharmacokinetic Blood Collection 12 hr span

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 19 (Visit 130): Pharmacokinetics, Vital Signs, Drug Administration9

- 21/12/2018 - 1 Formulaire, 4 Groupes Item, 27 Eléments de données, 1 Langue

Groupes Item: Administrative data, Study Drug Administration, Vital Signs, Pharmacokinetic Blood Collection

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

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