Resultados de la búsqueda - Portal de Modelos de Datos Médicos (MDM-Portal)

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - PGx - Pharmacogenetic Research

- 8/12/19 - 1 formulario, 5 itemgroups, 11 items, 1 idioma

Itemgroups: Administrative documentation, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Withdraw, Pharmacogenetic Test, Blood specimen, Destruction

Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy 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: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - PGx-Pharmacogenetic Research Consent

- 6/11/19 - 1 formulario, 2 itemgroups, 11 items, 1 idioma

Itemgroups: Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

- 20/9/21 - 1 formulario, 3 itemgroups, 28 items, 1 idioma

Itemgroups: Pharmacogenetic Research, prior medication, baseline signs and symptoms

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: Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs and Symptoms

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Pharmacogenetic Research

- 19/4/18 - 1 formulario, 4 itemgroups, 8 items, 1 idioma

Itemgroups: Consent for Pharmacogenetic Research, Blood sample collection, Withdrawal of consent, Blood Sample Destruction

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Pharmacogenetic Research.

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Pharmacogenetic Research (PGx)

- 27/6/18 - 1 formulario, 5 itemgroups, 12 items, 1 idioma

Itemgroups: Administrative Data, Consent for Pharmacogenetic Research, Pharmacogenetic sampling, Withdrawal of consent for pharmacogenetic research, Sample Destruction

This ODM file contains Pharmacogenetic (PGx) Research Information. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Pharmacogenetic (PGx) Research

- 17/12/19 - 1 formulario, 5 itemgroups, 12 items, 1 idioma

Itemgroups: Administrative documentation, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Withdraw, Pharmacogenetic Test, Blood specimen, Destruction

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy 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: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963 - PGx-Pharmacogenetic Research

- 22/4/19 - 1 formulario, 5 itemgroups, 9 items, 1 idioma

Itemgroups: Administrative documentation, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, DNA, Pharmacogenetic Test, Informed Consent, Withdraw, Pharmacogenetic Test, Blood specimen, Destruction

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Pharmacogenetics - Research Consent; Research Withdrawal of Consent

- 4/8/19 - 1 formulario, 2 itemgroups, 11 items, 1 idioma

Itemgroups: Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent

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 Lamictal on Resting Motor Threshold Study-ID 107434 - TMS Form (Treatment Periods)

- 25/1/19 - 1 formulario, 4 itemgroups, 23 items, 1 idioma

Itemgroups: Administrative Data, Rest Transcranial Magnetic Stimulation, Active Transcranial Magnetic Stimulation, Conclusion

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form is for documentation of the transcranial magnetic stimulation (TMS). TMS assessment to be performed in triplicate. The measurements are to be performed within 10 minutes of each other. It should be filled out at each treatment period. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Neurological Examination Form (Treatment period, Follow-up)

- 25/1/19 - 1 formulario, 2 itemgroups, 14 items, 1 idioma

Itemgroups: Administrative Data, Neurological Examintation

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form is for documentation of the neurological examination. It should be filled out at each treatment period visit and the follow up visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study ID 107434 - Unscheduled Laboratory Safety Test

- 25/1/19 - 1 formulario, 2 itemgroups, 11 items, 1 idioma

Itemgroups: Administrative Data, Unscheduled Laboratory Safety Tests

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any additional, unscheduled laboratory safety tests. It should be checked at each visit if any unscheduled laboratory safety tests were performed. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study ID 107434 - Clinical Laboratory Safety Tests 2

- 21/1/19 - 1 formulario, 4 itemgroups, 17 items, 1 idioma

Itemgroups: Administrative Data, Blood Samples, Urine Sample, Result Significance

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains informations about additional clinical laboratory safety tests. It should be filled out at each treatment period on admission, and on day 3, 48h00 post-dose. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

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