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58 Resultados de la búsqueda.
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 28, Pre-dose

- 29-04-22 - 1 formulario, 6 itemgroups, 47 items, 1 idioma
Itemgroups: Pregnancy Test, Drug Screen, Alcohol breath test, Carbon Monoxide test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 28, Pre-dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 1, Pre-dose

- 13-04-22 - 1 formulario, 6 itemgroups, 47 items, 2 idiomas
Itemgroups: Pregnancy Test, Drug Screen, Alcohol breath test, Carbon Monoxide test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 1, Pre-Dose.

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Alcohol Breath Test, Cotinine and Drugs Screenings (Screening and Sessions Visits)

- 20-09-21 - 1 formulario, 4 itemgroups, 9 items, 1 idioma
Itemgroups: Administrative Data, Alcohol Breath Test, Cotinine Screen, Drug Screen
This ODM file contains Alcohol Breath Test, Cotinine Screen and Drug Screening. To be filled in at Screening and Sessions 1 and 2 (Day -1). 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.

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

- 20-09-21 - 1 formulario, 18 itemgroups, 90 items, 1 idioma
Itemgroups: Note, Inclusion Criteria, Exclusion Criteria, 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 1 - 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 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 20-09-21 - 1 formulario, 17 itemgroups, 88 items, 1 idioma
Itemgroups: Note, Inclusion Criteria, Exclusion Criteria, Physical examination, orthostatic blood pressure / Pulse - Predose, Pregnancy test, Patient diary, Alcohol test, Urine drug screening, Concomitant medication, Adverse event, Randomization, Standard Breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - 4 hours post dosing, Discharge
PART A - Period 1 - 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

Substances - Lifetime Abuse and Dependence Protocol PhenX Toolkit

- 20-09-21 - 1 formulario, 1 itemgroup, 43 items, 1 idioma
Itemgroup: PhenX - substance - lifetime abuse and dependence protocol
Measurement of respondent’s signs of substance abuse and dependence. These responses correspond with criteria from the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV). There are two questions within each of which are multiple parts. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Day -1 - Pregnancy Test; Urine Test for Drugs of Abuse; Carbon Monoxide Test

- 19-01-21 - 1 formulario, 5 itemgroups, 10 items, 1 idioma
Itemgroups: Administrative, Pregnancy Test, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Carbon Monoxide Test
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - Alcohol Intake; Alcohol Breath Test; Urine Test for Drugs of Abuse; Urine Cotinine Test; History of Tobacco Use

- 07-01-21 - 1 formulario, 7 itemgroups, 14 items, 1 idioma
Itemgroups: Administrative, Alcohol Intake, Alcohol Breath Test, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Urine Cotinine Test, History of Tobacco Use
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Drug Screen, Alcohol Breath Test

- 15-05-20 - 1 formulario, 3 itemgroups, 14 items, 1 idioma
Itemgroups: Administrative Data, Drug Screening, Alcohol Breath Test
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Drug Screening and Alcohol Breath Test form has to be filled in at screening and at both pre-dose treatment examinations.

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Dosing Session 3

- 23-06-19 - 1 formulario, 6 itemgroups, 23 items, 1 idioma
Itemgroups: Administrative documentation, Prganancy Tests, Drug abuse, Vital Signs, Pharmacokinetic aspects, Sampling, Experimental drug
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Dosing Session 1

- 23-06-19 - 1 formulario, 6 itemgroups, 24 items, 1 idioma
Itemgroups: Administrative documentation, Prganancy Tests, Drug abuse, Vital Signs, Pharmacokinetic aspects, Sampling, Experimental drug
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Dosing Session 2

- 23-06-19 - 1 formulario, 6 itemgroups, 23 items, 1 idioma
Itemgroups: Administrative documentation, Prganancy Tests, Drug abuse, Vital Signs, Pharmacokinetic aspects, Sampling, Experimental drug
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

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