Clinical trials: Pharmacokinetic
Renal Impairment
Single-Dose PK Study of GBT440 in Subjects With Renal Impairment
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal…
- Trial name
- NCT03161015
- Testing
- GBT440
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Global Blood Therapeutics
Pain
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects…
- Trial name
- NCT02199574
- Testing
- EXPAREL
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Contraception
Desogestrel-containing COCP Pharmacokinetic Validation Study
This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of…
- Trial name
- NCT05002738
- Testing
- Desogestrel and Ethinyl Estradiol Tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Statin Pharmacokinetics Pre and Post Gastric Bypass Surgery
Rosuvastatin Interethnic PK Study
Statins are the first-line and most commonly prescribed drugs for the prevention of cardiovascular diseases and stroke in the world.
- Trial name
- RST (NCT02215174)
- Testing
- Rosuvastatin
- Where
- 2 sites in United States, Taiwan
- Volunteers
- 21 people
- Sponsor
- University of California, San Francisco
Inflammatory Bowel Disease
A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
Patients with inflammatory bowel disease (IBD) who require methotrexate (MTX)for treatment currently receive this drug by injection.
- Trial name
- NCT00035074
- Testing
- Methotrexate
- Where
- United States
- Sponsor
- National Center for Research Resources (NCRR)
Infection, Bacterial
A First-in-Human Study With XAB05 in Healthy Subjects
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
- Trial name
- NCT05307406
- Testing
- Experimental
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Xenothera SAS
Pharmacokinetics of Ciprofloxacin in Neonates
TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates
Phase I, open-label study to evaluate the pharmacokinetics, tolerability and short-term safety of ciprofloxacin in neonates with suspected (or proven) Gram Negative infection.
- Trial name
- TINN-PK (NCT01319435)
- Testing
- Collection of biological samples
- Where
- 2 sites in United Kingdom
- Volunteers
- 63 people
- Sponsor
- Liverpool Women's NHS Foundation Trust
Healthy
A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers
This is a single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups.
- Trial name
- NCT01587313
- Testing
- Isosorbide dinitrate / hydralazine capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Arbor Pharmaceuticals, Inc.
Peanut Allergies
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
The goal of this clinical trial is to evaluate the safety, pharmacokinetics, and effectiveness of MY006, a therapy designed to prevent severe or potentially life-threatening allergic reactions caused by accidental peanut intake.
- Trial name
- NCT07287033
- Testing
- MY006 Low Dose, MY006 Mid Dose, MY006 High Dose
- Where
- 9 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mabylon AG
Major Depressive Disorder
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD).
- Trial name
- NCT03965858
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Alzheimer Disease
Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered
The purpose of this study is to evaluate the effects of multiple doses of verapamil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of…
- Trial name
- NCT00745576
- Testing
- SAM-531
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
- Trial name
- NCT06360874
- Testing
- ND-003 40mg, ND-003 80mg, ND-003 160mg
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Shenzhen NewDEL Biotech, Co., Ltd
Pneumocystis Jirovecii Pneumonia
A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
In this study, we aim to investigate the incidence of the adverse reactions, the effectiveness and the gene polymorphism associated with the plasma level of sulfamethoxazole-trimethoprim and their metabolites (including…
- Trial name
- NCT02045160
- Where
- 2 sites in Taiwan
- Volunteers
- 1,000 people
- Sponsor
- National Taiwan University Hospital
Kidney Transplantation
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
- Trial name
- NCT01279538
- Testing
- bleselumab
- Where
- 21 sites in United States
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Hypertension, Dyslipidemia
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- Trial name
- NCT07682948
- Testing
- Investigational Product 1, Investigational Product 2, Investigational Product 1 + Investigational Product 2
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Amyotrophic Lateral Sclerosis
Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)
This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.
- Trial name
- NCT04569435
- Testing
- ANX005
- Where
- 8 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Annexon, Inc.
Patients With Chemotherapy Induced Anemia (CIA)
Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.
- Trial name
- PK-CIA-06 (NCT01280240)
- Testing
- Monofer(R)
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pharmacosmos A/S
Glucose and Insulin Response
Glycemic Response of a Commercial Food Bar
The purpose of this study is to examine the glucose and insulin response to a food bar.
- Trial name
- NB16 (NCT03166514)
- Testing
- Commercially Available Food Bar
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Texas A&M University
Healthy
Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
The impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as AT1R…
- Trial name
- NCT00310778
- Testing
- high sodium diet, low sodium diet, ramipril 10 mg
- Where
- France
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor
Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
- Conditions
- Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney Cancer
- Trial name
- NCT00020150
- Testing
- O6-benzylguanine, temozolomide
- Where
- United States
- Sponsor
- National Cancer Institute (NCI)
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