Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

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

- 09.04.19 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: 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

- 09.04.19 - 1 Formular, 3 Itemgruppen, 18 Datenelemente, 1 Sprache

Itemgruppen: 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 - Plasma Drug Assay

- 09.04.19 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: 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 - Alcohol Consumption, Smoking History

- 09.04.19 - 1 Formular, 4 Itemgruppen, 9 Datenelemente, 1 Sprache

Itemgruppen: 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

- 09.04.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: 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 - Demographic Details, demography for females

- 09.04.19 - 1 Formular, 5 Itemgruppen, 27 Datenelemente, 1 Sprache

Itemgruppen: 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

- 08.04.19 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: 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

- 08.04.19 - 1 Formular, 3 Itemgruppen, 22 Datenelemente, 1 Sprache

Itemgruppen: 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 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

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

- 09.10.17 - 1 Formular, 2 Itemgruppen, 34 Datenelemente, 1 Sprache

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

- 09.10.17 - 1 Formular, 1 Itemgruppe, 13 Datenelemente, 1 Sprache

Itemgruppe: Adverse Event

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: Adverse Event

Stichworte

Inhaltsverzeichnis

Ausgewählte Datenmodelle