Keywords
Pharmacokinetics ×
Show more Keywords
Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

You must log in to select data models for download or further analysis.

328 Search results.

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

- 5/10/21 - 1 form, 10 itemgroups, 79 items, 1 language
Itemgroups: 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

- 5/10/21 - 1 form, 17 itemgroups, 57 items, 1 language
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

PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 4/13/21 - 1 form, 18 itemgroups, 90 items, 1 language
Itemgroups: Note, Inclusion Criteria, Exclusion Criteria, Physical examination, Pregnancy test, Alcohol test, Urine drug screening, orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Randomization, High fat breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - post dosing, Pharmacokinetic sampling post dosing, Discharge
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day 1 - Summary Holter; Summary Holter Abnormalities; Electronically Transferred Lab Data; Pharmacokinetics Blood; Urinalysis

- 4/10/21 - 1 form, 24 itemgroups, 323 items, 1 language
Itemgroups: Date of Visit, Summary Holter, Summary Holter Abnormalities, Electroniclly Transferred Lab Data - Dosing Date and Time, Electronically Transerred Lab Data - Pre-dose, Electronically Transerred Lab Data - 1 Hour, Electronically Transerred Lab Data - 2 Hour , Electronically Transerred Lab Data - 4 Hour, Electronically Transerred Lab Data - 8 Hour , Electronically Transerred Lab Data - 24 Hour, Electronically Transerred Lab Data - 36 Hour , Electronically Transerred Lab Data - 48 Hour, Electronically Transerred Lab Data - 72 Hour , Pharmacokinetics Blood, Pharmacokinetics Blood - Extra Scheduled Samples Entry , Urinalysis - Dosing Date and Time , Urinalysis Dipstick Details - Pre-Dose, Urinalysis Dipstick Details - 2 Hour Post-Dose, Urinalysis Dipstick Details - 4 Hour Post-Dose , Urinalysis Dipstick Details - 8 Hour Post-Dose , Urinalysis Dipstick Details - 24 Hour Post-Dose , Urinalysis Dipstick Details -36 Hour Post-Dose, Urinalysis Dipstick Details -48 Hour Post-Dose , Urinalysis - Local: Microscopy Details
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

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

- 2/15/21 - 1 form, 21 itemgroups, 47 items, 1 language
Itemgroups: 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

- 1/9/21 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: 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

- 1/9/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: 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

- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: 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

- 1/2/21 - 1 form, 20 itemgroups, 72 items, 1 language
Itemgroups: 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

- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: 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

- 1/2/21 - 1 form, 20 itemgroups, 72 items, 1 language
Itemgroups: 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

- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: 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