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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - Logs and Repeats

- 17/09/2021 - 1 Formulário, 2 Grupos de itens, 12 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Adverse Event | Concomitant Medication | Evaluation
This form documents if any measurements were repeated during the study, if concomitant medications were taken or if any adverse events or ECG abnormalities occurred. To be assessed at study conclusion. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - ECG Abnormalities

- 17/09/2021 - 1 Formulário, 8 Grupos de itens, 93 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, 12-Lead ECG Abnormalities, Rhythm, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities
This form documents the recorded abnormalities on ECG. To be filled in continously. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics

- 10/05/2021 - 1 Formulário, 10 Grupos de itens, 79 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Date of visit/assessment, Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions, Adverse Events, Concomitant Medications, 12-Lead/ Holter/ Telemetry ECG, 12-Lead ECG Abnormalities, Vital Signs, Pharmacokinetics, Orthostatic Vital Signs
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

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

- 10/05/2021 - 1 Formulário, 17 Grupos de itens, 57 Elementos de dados, 1 Idioma
Grupos de itens: 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

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Treatment Period 1 - 5 - Pharmacokinetics; Pharmacodynamics; Local Laboratory; Urinalysis;

- 15/02/2021 - 1 Formulário, 21 Grupos de itens, 47 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Pharmacokinetics - Blood Sample (Odd Numbered Subjects) (Day 7), Pharmacokinetics - Blood Sample (Even Numbered Subjects) (Day 7) , Pharmacodynamics - Blood Sample (Day 7), Pharmacodynamics Urine Cortisol (Day 7 - Post-Dose), Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose), Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose) , Local Laboratory - Haematology (Day 7 - Pre-Dose), Local Laboratory - Haematology (Day 7 - Pre-Dose) , Urinalysis - Local (Day 7 - Pre-Dose), Urinalysis - Local (Day 7 - Pre-Dose) , Urinalysis - Microscopy (Day 7 - Pre-Dose) , Urinalysis - Microscopy (Day 7 - Pre-Dose) , Clinical Chemistry (Day 7 - Post-Dose) , Local Laboratory - Clinical Chemistry (Day 7 - Post-Dose) , Local Laboratory - Haematology (Day 7 - Post-Dose) , Local Laboratory - Haematology (Day 7 - Post-Dose), Urinalysis - Local (Day 7 - Post-Dose) , Urinalysis - Local (Day 7 - Post-Dose), Urinalysis - Microscopy (Day 7 - Post-Dose), Urinalysis - Microscopy (Day 7 - Post-Dose)
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Pharmacokinetics Repeat

- 09/01/2021 - 1 Formulário, 2 Grupos de itens, 5 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Pharmacokinetics Blood, Repeat
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents any repeating Pharmacokinetics Blood measurements.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Pharmacokinetics, week 1, 2 and 3

- 09/01/2021 - 1 Formulário, 2 Grupos de itens, 17 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Dosing date and time
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. Pharmacokinetics Blood measurements are supposed to be made ar the week 1, 2 and 3 visits.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 1, Cohort 1: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 02/01/2021 - 1 Formulário, 21 Grupos de itens, 84 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Local Laboratory - Haematology (Period 1), Local Laboratory - Haematology (Period 1), Local Laboratory - Clinical Chemistry (Period 1), Local Laboratory - Clinical Chemistry (Period 1), Investigational Product (Dose) (Period 1), ECG (Period 1), Vital Signs (Period 1), Local Laboratory - Haematology (24Hr Lab) (Period 1), Local Laboratory - Haematology (24 Hr Lab) (Period 1), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1), Pharmacokinetics Blood (Period 1), Pharmacokinetics Blood (Period 1), Pharmacokinetics Urine (Period 1), Pharmacokinetics Urine (Period 1), Summary Holter (Period 1), Summary Holter (Period 1) (Pre-Dose - 24 hours), Holter Abnormalities (Period 1), Holter Abnormalities (Period 1), Pulmonary Function Tests (Period 1)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 2, Cohort 1 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 02/01/2021 - 1 Formulário, 20 Grupos de itens, 72 Elementos de dados, 1 Idioma
Grupos de itens: Date of visit, Investigational Product (Dose) (Part 2 Period 2), ECG (Part 2 Period 2), ECG (Part 2 Period 2), Vital Signs (Part 2 Period 2), Vital Signs (Part 2 Period 2), Pulmonary Function Tests (Part 2 Period 2), Pulmonary Function Tests (Part 2 Period 2), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 2), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 2), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 2), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 2), Pharmacokinetics Blood (Part 2 Period 2), Pharmacokinetics Blood (Part 2 Period 2), Pharmacokinetics Urine (Part 2 Period 2), Pharmacokinetics Urine (Part 2 Period 2), Summary Holter (Part 2 Period 2), Summary Holter (Part 2 Period 2) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 2), Holter Abnormalities (Part 2 Period 2)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 3, Cohort 1: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 02/01/2021 - 1 Formulário, 21 Grupos de itens, 84 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Local Laboratory - Haematology (Period 3), Local Laboratory - Haematology (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Investigational Product (Dose) (Period 3), ECG (Period 3), Vital Signs (Period 3), Local Laboratory - Haematology (24Hr Lab) (Period 3), Local Laboratory - Haematology (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Urine (Period 3), Pharmacokinetics Urine (Period 3), Summary Holter (Period 3), Summary Holter (Period 3) (Pre-Dose - 24 hours), Holter Abnormalities (Period 3), Holter Abnormalities (Period 3), Pulmonary Function Tests (Period 3)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 1 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 02/01/2021 - 1 Formulário, 20 Grupos de itens, 72 Elementos de dados, 1 Idioma
Grupos de itens: Date of visit, Investigational Product (Dose) (Part 2 Period 4) , Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , ECG (Part 2 Period 4) , ECG (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Summary Holter (Part 2 Period 4) , Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 4) , Holter Abnormalities (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 3, Cohort 2: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 02/01/2021 - 1 Formulário, 21 Grupos de itens, 84 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Local Laboratory - Haematology (Period 3), Local Laboratory - Haematology (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Investigational Product (Dose) (Period 3), ECG (Period 3), Vital Signs (Period 3), Local Laboratory - Haematology (24Hr Lab) (Period 3), Local Laboratory - Haematology (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Urine (Period 3), Pharmacokinetics Urine (Period 3), Summary Holter (Period 3), Summary Holter (Period 3) (Pre-Dose - 24 hours), Holter Abnormalities (Period 3), Holter Abnormalities (Period 3), Pulmonary Function Tests (Period 3)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

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