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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Concomitant Medication, Adverse Event

- 06.08.17 - 1 Formular, 2 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: concomitant medication, adverse event
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Concomitant Medication, Adverse Event

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

- 05.08.17 - 1 Formular, 3 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: clinical chemistry and hematology, pregnancy information, study conlcusion
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

- 06.08.17 - 1 Formular, 5 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: serious adverse event, laboratory data, death form, investigator comment log, investigator checklist
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

- 05.08.17 - 1 Formular, 4 Itemgruppen, 26 Datenelemente, 1 Sprache
Itemgruppen: phaysical examination, serum b-hcg pregnancy test, vital signs, 12-lead ecg monitoring
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Physical Examination, b-HCG Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

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