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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Screening - Informed Consent; Admission Criteria; Demographics; Electocardiogram; Central Laboratory

- 29/11/20 - 1 modulo, 10 itemgroups, 48 elementi, 1 linguaggio

Itemgroups: Administrative, Informed Consent, Admission Criteria, Admission Criteria , Demographics, Electrocardiogram, Central Laboratory - Haematology, Central Laboratory - Chemistry/ Serum HCG/ SP Chem, Central Laboratory - UA/ UDS/ Urine Chem , Central Laboratory - Serology

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Screening - Vital Signs; General Medical History; Physical Exam

- 29/11/20 - 1 modulo, 5 itemgroups, 25 elementi, 1 linguaggio

Itemgroups: Administrative, Vital Signs (sitting), General Medical History, Physical Exam, Physical Exam

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day -1 - Admission Criteria; Vital Signs; Electrocardiogram; Central Laboratory

- 29/11/20 - 1 modulo, 7 itemgroups, 39 elementi, 1 linguaggio

Itemgroups: Administrative, Admission Criteria, Vital Signs (sitting) , Electrocardiogram, Central Laboratory - Haematology , Central Laboratory - Chemistry, Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Adverse Events/ Serious Adverse Events; Prior and Concomitant Medications/ Non-drug Therapies

- 29/11/20 - 1 modulo, 15 itemgroups, 57 elementi, 1 linguaggio

Itemgroups: Administrative, Adverse Events, Adverse Events/ Serious Adverse Events - Section 1, Adverse Events/ Serious Adverse Events - Section 2 (Seriousness), Adverse Events/ Serious Adverse Events - Section 3 (Demography Data), Adverse Events/ Serious Adverse Events - Section 4, Adverse Events/ Serious Adverse Events - Section 5, Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions), Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors) , Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications) , Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s)) , Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS) , Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks), Prior and Concomitant Medications/Non-drug Therapies , Prior and Concomitant Medications/Non-drug Therapies

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Pregnancy Information

- 29/11/20 - 1 modulo, 6 itemgroups, 63 elementi, 1 linguaggio

Itemgroups: Administrative , Demography and Medical History (Pregnancy Notification Form), Pregnancy Information (Pregnancy Notification Form) , Demography and Medical History (Pregnancy Outcome Form), Child Information (Pregnancy Outcome Form), Pregnancy Outcome Information (Pregnancy Outcome Form)

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Liver Biopsy; Liver Events Assessment; Liver Imaging; Liver Event Follow-Up Chemistries

- 29/11/20 - 1 modulo, 10 itemgroups, 80 elementi, 1 linguaggio

Itemgroups: Administrative, Liver Biopsy, Liver Events Assessment, Liver Events, Liver Disease Medical Conditions, Drug related Liver Disease Conditions, Other Liver Disease Conditions, Other Medical Conditions, Liver Imaging, Liver event follow-up chemistries

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - New Thyroid Nodules

- 29/11/20 - 1 modulo, 3 itemgroups, 22 elementi, 1 linguaggio

Itemgroups: Administrative , New Thyroid Nodules, Thyroid function

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Pancreatitis

- 29/11/20 - 1 modulo, 12 itemgroups, 56 elementi, 1 linguaggio

Itemgroups: Administrative, Pancreatitis, Alcohol, Family History of Pancreatitis, Family History of Pancreatitis, Pancreatitis - Recent trauma/vascular invasive procedures or surgery, Symptoms of gastrointestinal illness associated with pancreatitis, Other symptoms associated with pancreatitis, Pancreatitis - Lab results (Biochemistry), Pancreatitis - Lab results (Biochemistry) , Pancreatitis - Additional Lab results (Biochemistry), Pancreatitis - Diagnostic studies

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 1 - 5: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Simvastatin)

- 29/11/20 - 1 modulo, 8 itemgroups, 42 elementi, 1 linguaggio

Itemgroups: Administrative, Vital Signs (sitting) - Day 1 - 5, Study Drug Administration (80 mg Simvastatin) - Day 1, Pharmacokinetic Blood Collection (Simvastatin) - Day 1, Pharmacokinetic Blood Collection (Simvastatin) - Day 2 , Pharmacokinetic Blood Collection (Simvastatin) - Day 3, Pharmacokinetic Blood Collection (Simvastatin) - Day 4, Pharmacokinetic Blood Collection (Simvastatin) - Day 5

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

- 29/11/20 - 1 modulo, 9 itemgroups, 82 elementi, 1 linguaggio

Itemgroups: Administrative, Study Completion, Vital Signs (Unscheduled), Physical Examination (Unscheduled Visit), Electrocardiogram (Unscheduled), Central Laboratory Blood (Unscheduled), Central Laboratory Urine (Unscheduled) , Hypoglycaemia, Injection Site Reaction

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

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