Clinical trials: Area Under Curve
HIV Infections
Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women
The purpose of this study is to find out if the anti-HIV drugs nelfinavir (NFV), lopinavir/ritonavir (LPV/r), and efavirenz (EFV) change the amount of estrogen in the blood when taken along with hormone replacement therapy (HRT)…
- Trial name
- NCT00044837
- Testing
- Medroxyprogesterone acetate, Estradiol
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.
This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants.
- Trial name
- NCT04111614
- Testing
- Tofacitinib tablet, Tofacitinib Oral Solution
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infections, Lipodystrophy
Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities
The purpose of this study is to see whether metformin alone, rosiglitazone alone, or metformin and rosiglitazone together will lower insulin levels in the blood and decrease fat in the abdomen or other parts of the body.
- Conditions
- HIV Infections, Lipodystrophy, Hyperinsulinemia
- Trial name
- NCT00015691
- Testing
- Metformin hydrochloride, Rosiglitazone maleate
- Where
- 34 sites in United States
- Volunteers
- 105 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
COPD
TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD
Efficacy of TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on lung stiffness reduction assessed through area under the reactance curve (AX) using oscillometry in chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT04671355
- Testing
- Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg, Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg
- Sponsor
- Chiesi Farmaceutici S.p.A.
Kidney Transplantation
Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch
The goal of this clinical trial is to learn if calcineurin-inhibitor therapy (a drug commonly used to prevent rejection) can be safely stopped in kidney transplant recipients with a relatively low risk of rejection (being…
- Trial name
- MyQURE (NCT06493526)
- Testing
- Withdrawal of calcineurin-inhibitor, continue on concentration-controlled mycophenolate mofetil and corticosteroids.
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- University Hospital, Antwerp
Cystic Fibrosis
Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis
Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the long term damage to their lungs from infection.
- Trial name
- NCT02489955
- Testing
- Amikacin, Tobramycin, Colomycin
- Where
- United Kingdom
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Ornithine Transcarbamylase Deficiency
A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects
The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.
- Trial name
- NCT04269122
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ultragenyx Pharmaceutical Inc
Kidney Transplant Recipients
Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term.
- Trial name
- NCT00199667
- Testing
- Mycophenolate Mofetil
- Where
- 11 sites in France
- Volunteers
- 137 people
- Sponsor
- University Hospital, Limoges
HIV Infections
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with…
- Trial name
- NCT00000893
- Testing
- Nelfinavir mesylate, Efavirenz
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 103 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastric Bypass, Depression
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
The morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs.
- Conditions
- Gastric Bypass, Depression, Anxiety Disorder
- Trial name
- NCT01317147
- Testing
- Roux-en-Y gastric bypass (RYGBP)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Pittsburgh
Colorectal Cancer
Pharmacology-driven Dosing of Fluoropyrimidines in Cancer Patients
The fluoropyrimidines 5-fluorouracil (5FU) and capecitabine (Cp) are among the most commonly used anticancer drugs. Still, there is much controversy about the correct dosing, and the fact that a minority of patients experience…
- Trial name
- FLOXTOX2 (NCT01641458)
- Testing
- 5FU and capecitabine (Xeloda®) dosing based on DPYD genotype, Therapeutic drug monitoring of 5FU
- Where
- 2 sites in Switzerland
- Volunteers
- 37 people
- Sponsor
- Cantonal Hospital of St. Gallen
Dietary Modification, Diabetes Mellitus Type 2
Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus
To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes.
- Conditions
- Dietary Modification, Diabetes Mellitus Type 2, Insulin Tolerance, Diabetic Blood Glucose Monitoring
- Trial name
- NCT02204384
- Testing
- HFD Meal: High fiber from food, HFS Meal: High fiber from supplement, UF Meal: usual amount of fiber
- Where
- Brazil
- Volunteers
- 19 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Methicillin-resistant Staphylococcus Aureus Septicemia
The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?
The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.
- Trial name
- NCT01995760
- Where
- Taiwan
- Volunteers
- 123 people
- Sponsor
- National Taiwan University Hospital
Solid Tumours
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function…
- Trial name
- NCT02161770
- Testing
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Area Under Curve [N06.850.520.830.200]
Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.
Postprandial glycaemic control is an important risk factor for the development of type 2 diabetes, cardiovascular disease and all-cause mortality.
- Trial name
- NCT01987687
- Testing
- Exercise, Rest, Delay
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Northumbria University
Systemic Sclerosis
MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis
To define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse cutaneous or interstitial lung damage of…
- Trial name
- SCLERAMAC (NCT04244916)
- Testing
- AUC of MPA measure
- Where
- France
- Volunteers
- 2 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HIV Infections, Hepatitis C
Effects of Ribavirin on Zidovudine or Stavudine
The purpose of this study is to see how treatment of hepatitis C (HCV) patients with ribavirin (RBV) affects the anti-HIV drugs stavudine (d4T) or zidovudine (ZDV).
- Trial name
- NCT00021632
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Solid Tumours
To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
This is a 3 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating and the effect of olaparib on QT…
- Trial name
- NCT01921140
- Testing
- Olaparib tablets, Pharmacokinetic sampling, Dietary Fasted
- Where
- 12 sites in Belgium, Denmark and 2 more
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
Healthy Participants
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy…
- Trial name
- NCT04916769
- Testing
- Bosutinib capsule
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Attention Deficit Hyperactivity Disorder
Pharmacokinetics of Two Extended-Release Formulations of Methylphenidate in Children With Attention Deficit Hyperactivity Disorder (ADHD)
This study is designed to provide pharmacokinetic data for the assessment of bioequivalence of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy measures.
- Trial name
- MPH-Kinetics (NCT00772161)
- Testing
- Methylphenidate
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- University Hospital Freiburg