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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Electrocardiography

- 09/04/2019 - 1 Formulaire, 2 Groupes Item, 13 Eléments de données, 1 Langue
Groupes Item: Administrative data, 12 LEAD ECG
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Electrocardiography form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Electrocardiography/ Cardiovascular Monitoring for Screening and Follow-up

- 09/04/2019 - 1 Formulaire, 3 Groupes Item, 18 Eléments de données, 1 Langue
Groupes Item: Administrative data, 12 LEAD ECG, Blood pressure measurement
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Electrocardiography/ Cardiovascular Monitoring form. It has to be filled in for screening and follow-up.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Alcohol Consumption, Smoking History

- 09/04/2019 - 1 Formulaire, 4 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Administrative data, Alcohol Consumption, Smoking History, Smoking history details
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Alcohol Consumption and Smoking History form. It has to be filled in for screening.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Predose Drug Screening/Alcohol Breath Test

- 09/04/2019 - 1 Formulaire, 3 Groupes Item, 11 Eléments de données, 1 Langue
Groupes Item: Administrative data, Drug Screening, Alcohol breath test
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Predose Drug Screening/Alcohol Breath Test form. It has to be filled in for all Sessions each on Day 1 and for screening.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Plasma Drug Assay

- 09/04/2019 - 1 Formulaire, 2 Groupes Item, 12 Eléments de données, 1 Langue
Groupes Item: Administrative data, Plasma Drug Assay
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Plasma Drug Assay fomr. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Demographic Details, demography for females

- 09/04/2019 - 1 Formulaire, 5 Groupes Item, 27 Eléments de données, 1 Langue
Groupes Item: Administrative data, Demographic Details, Racial group, Childbearing potential, Pregnancy Test
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Demographic Details and demography for females form. It has to be filled in for screening.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Significant Medical/Surgical History, Physical examination

- 08/04/2019 - 1 Formulaire, 3 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Administrative data, Significant Medical/Surgical History, Physical Examination
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Significant Medical/Surgical History and Physical examination. Both has to be filled in for screening. Physical examination has to be filled in for Follow-up too.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Eligibility criteria

- 08/04/2019 - 1 Formulaire, 3 Groupes Item, 22 Eléments de données, 1 Langue
Groupes Item: Administrative data, Inclusion Criteria, Exclusion Criteria
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the eligibility criteria. It has to be filled in for screening.

Dose strength equivalence of ropinirole CR in healthy adults Serious Adverse Event 101468/219 - Serious Adverse Event Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09/10/2017 - 1 Formulaire, 2 Groupes Item, 34 Eléments de données, 1 Langue
Groupes Item: Serious Adverse Event, Relevant Laboratory Data
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: Serious Adverse Event

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

- 09/10/2017 - 1 Formulaire, 3 Groupes Item, 28 Eléments de données, 1 Langue
Groupes Item: Demography, Inclusion Criteria, Exclusion Criteria
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: Screening

Dose strength equivalence of ropinirole CR in healthy adults Form D 101468/219 - Form D Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09/10/2017 - 1 Formulaire, 1 Groupe Item, 4 Eléments de données, 1 Langue
Groupe Item: Form D
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: Form D

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

- 09/10/2017 - 1 Formulaire, 1 Groupe Item, 9 Eléments de données, 1 Langue
Groupe Item: 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

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