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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Concomitant Vaccination 111028 - Concomitant Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111028

- 09.10.17 - 1 Formular, 3 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: Concomitant Vaccination, Medication, Non-serious Adverse Events
Study ID: 111028 Clinical Study ID: 111028 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Concomitant Vaccination

Dose strength equivalence of ropinirole CR in healthy adults Prior Medication 101468/219 - Prior Medication Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09.10.17 - 1 Formular, 1 Itemgruppe, 9 Datenelemente, 1 Sprache
Itemgruppe: Prior Medication
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Prior Medication

Dose strength equivalence of ropinirole CR in healthy adults Concomitant Medication 101468/219 - Concomitant Medication Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09.10.17 - 1 Formular, 1 Itemgruppe, 9 Datenelemente, 1 Sprache
Itemgruppe: Concomitant Medication
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Concomitant Medication

PART B - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 16 Itemgruppen, 61 Datenelemente, 1 Sprache
Itemgruppen: Note, 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 2 - 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

PART A - Period 2 - Day 5 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 10 Itemgruppen, 35 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - 4 hours post dosing, Completion of Part A, Discharge
PART A - Period 2 - Day 5 - 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

PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 11 Itemgruppen, 49 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Study Drug Dosing - Lunch, Study Drug Dosing - Dinner, Pharmacokinetic sampling post dosing (CR), Pharmacokinetic sampling post dosing (IR)
PART A - Period 2 - Day 4 - 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

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

- 03.10.17 - 1 Formular, 11 Itemgruppen, 49 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Study Drug Dosing - Lunch, Study Drug Dosing - Dinner, Pharmacokinetic sampling post dosing (CR), Pharmacokinetic sampling post dosing (IR)
PART A - Period 1 - PK Sampling Day - 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

PART A - Period 2 - Day 3 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 8 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Discharge
PART A - Period 2 - Day 3 - 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

PART A - Period 2 - Day 2 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 8 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Discharge
PART A - Period 2 - Day 2 - 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

PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 12 Itemgruppen, 52 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Pregnancy test, Patient diary, Alcohol test, Urine drug screening, Concomitant medication, Adverse event, Standard Breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - 4 hours post dosing, Discharge
PART A - Period 2 - 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

PART A - Period 1 - Day 2 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 8 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Discharge
PART A - Period 1 - Day 2 - 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

PART A - Period 1 - Day 3 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 03.10.17 - 1 Formular, 8 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Discharge
PART A - Period 1 - Day 3 - 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

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