View clinical trials related to Drug Interaction.
Filter by:A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva. The study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
Preliminary studies have shown that before giving combined acupuncture and medicine anesthesia, electroacupuncture (EA) needs to be started three days before in order to produce a sequential effect. In combined acupuncture and drug anesthesia, the core goal is to use acupuncture to reduce the insufficiency of anesthetics in terms of analgesia, sedation, stable circulation, and protection of organs. However, the mechanism of action behind this combination has not yet been changed. The pharmacodynamics or pharmacokinetics has been convincingly explained, or the degree of recognition is not high, such as whether acupuncture has a specific target in the body, if there is a specific target, where the effect target is located ? Will it affect the metabolic enzymes and will it further affect the efficacy or toxicity of the drugs metabolized by the metabolic enzymes? What effect will it have on the pharmacokinetic mechanism? Given that it may involve complex pharmacodynamics and pharmacokinetic mechanisms, this study will first use doxofylline (DOXO) as a probe to study and explain its effect on metabolic enzymes to further clarify whether it will produce therapeutic drugs Influence. Doxofylline (DOXO), as an old drug that has been used for many years, has extremely high safety and strong selectivity. It is a clinical drug with an injectable dosage form. Studies have proved that DOXO can be used as a high-quality P450 mixed-function oxidase CYP1A in vivo probe. DOXO is a metabolic clearance-leading drug in the human body, and it must undergo the initiation metabolism of CYP1A in the cell to be transformed into theophylline acetaldehyde ( TA), and then theophylline acetic acid (TAA) and hydroxyethyl theophylline (ETO) produced by disproportionation. Therefore, quantitative detection of TAA and ETO can calculate the maximum activity of CYP1A. In order to study the kinetics of DOXO and reduce the inconvenience of excessive blood sampling points for long-term continuous administration, we will explore the method of detecting DOXO kinetics by the Vmax method through clinical research to characterize whether acupuncture affects the metabolic enzyme CYP1A
This study is a single-center, open-label, 2-cohort, multiple dose, fixed-sequence, DDI study in healthy adult subjects. Healthy volunteers will be administered multiple oral doses of ATI-2173 in combination with tenofovir disoproxil fumarate and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the investigational drug interacts with tenofovir disoproxil fumarate.
This project includes two separate pharmacokinetic studies with simvastatin and rosuvastatin, respectively. Each study is an open-label, single-dose, randomized, three-phase (no herbs, with green tea, with soy isoflavones) clinical pharmacokinetic study design with a wash-out of at least 4-weeks between phases. The aim is to examine whether green tea extract and soy isoflavones affect the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects and whether these interactions are influenced by polymorphisms in the relevant drug transporters, solute carrier 1B1 (SLCO1B1) and adenosine triphosphate (ATP) binding cassette G2 (ABCG2) and to identify whether polymorphisms in drug transporters influence the pharmacokinetics of simvastatin and rosuvastatin. After informed consent is obtained, subjects are required to abstain from any prescription or non-prescription medications 2 weeks before and throughout the study. Subjects are given a single dose of simvastatin 20 mg (Zocor®, MSD) or rosuvastatin 10 mg (Crestor®, Astra Zeneca) on 3 occasions: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract. The green tea extract and soy isoflavones extract are given at a dose containing epigallocatechin gallate (EGCG) 800 mg once daily or isoflavones 120 mg once daily for 14 days before statin dosing with at least 4-week washout period between phases. Blood samples are taken at intervals from 0 to 24 hours on the statin dosing days. During the study, subjects are reminded frequently of the requirements on diet.
This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.
The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
The purpose of this is to evaluate the effect of food and the effect of a proton pump inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib.
This is a drug-drug interaction (DDI) study of mirtazapine for methamphetamine (MA) use disorder (MUD) to ensure the safety of this medication in the presence of a relevant dose of MA for people actively-using MA. Aim 1: To determine if mirtazapine alters the cardiovascular response to IV MA. Aim 2: To determine if the pharmacokinetics of IV MA are altered by mirtazapine administration. Aim 3: To evaluate the above aims in the setting of concomitant administration of methadone. This study involves two simultaneous within-subject drug-drug interaction studies, each comprised of 12 participants. A total of 24 subjects will be enrolled who have methamphetamine use disorder who will be classified into 2 groups: (Group 1: no opioids; Group 2: opioid use disorder on methadone maintenance). Subjects will be randomized to the order of mirtazapine and placebo (i.e. one-half will receive mirtazapine first, then placebo; one-half will receive placebo first, then mirtazapine).
The proposed study will assess the drug interaction potential between oral cannabidiol (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12 healthy research subjects