View clinical trials related to Pharmacokinetics.
Filter by:The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery
Chronic myeloid leukemia (CML) consists of 3 clinical stages including chronic phase, accelerated phase and blast crisis. Patients may only survive for few more days to weeks once the disease progresses to blast crisis, even though they might have been stable for several years in the chronic phase. The standard treatment, continuous use of tyrosine kinase inhibitors (TKIs), improves long-term survival, and even may help patients achieve complete remission. Four TKIs are reimbursed by National Health Insurance in Taiwan. Among them, imatinib, nilotinib as well as dasatinib, and ponatinib are the first, second and third generations of TKIs, respectively. Many factors influence the disease control of CML, such as TKI type, genetic mutation and medication adherence. Only 69% of patients followed their physicians' recommendations in a local survey. The medication adherence of TKIs was compromised based on several clinical studies domestically and worldwide due to the slow progression in the chronic phase. Patients might hold or decrease the dose of TKIs on their own when they suffer side effects. Furthermore, the significant intra-subject variations of TKI plasma concentration and drug-drug and drug-food interactions which alter the metabolism of TKIs may lessen therapeutic effect and patient safety. Therefore, this study aims to develop and validate analytic methods of imatinib, dasatinib, nilotinib and ponatinib plasma concentrations. The investigators plan to build the pharmacokinetic models of these 4 TKIs and analyze the impacts of meals, adherence, hepatic enzyme inhibitors and inducers, antacids, proton pump inhibitors and H2 blockers, etc. Adverse drug reactions and treatment outcomes will be evaluated to determine the availability and feasibility of therapeutic drug monitoring of TKIs as part of routine service in pharmacist-led clinics.
Preoperative antimicrobial prophylaxis is a key element for the prevention of surgical site infection, the most common type of nosocomial infection in surgical patients. Prophylactic antibiotics are selected depending on the type of surgery, and first- or second-generation cephalosporins have been mainly used. Cefoxitin, a second-generation cephalosporin with anaerobic activity, has been used in various clinical settings as a prophylactic antibiotic for colorectal surgery. Cefoxitin is generally dissolved in normal saline and intravenously administered for a short time of 5-10 minutes before skin incision. However, there are several drawbacks to the current dosing strategy. First, the dose of cefazolin is determined by a "rule of thumb", and there is controversy over whether 1 g or 2 g is appropriate, with the opinion that 2 g being more appropriate prevailing. Second, the standard administration method unnecessarily induces a concentration higher than the concentration required to prevent surgical site infection. Third, significant covariates that can affect the maintenance of MIC during surgery are not considered. The target-concentration controlled infusion (TCI) method can be a viable alternative administration method for antibiotics. The TCI method enables individual customized administration according to the covariates (i.e., weight, creatinine clearance) included in the pharmacokinetic parameters; also, although with some variability, the drug can be administered while maintaining the target concentration. The aim of this study was to evaluate the effectiveness of administering cefoxitin in patients undergoing colorectal surgery with a syringe pump equipped with a target concentration control injection function
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of rocuronium-induced moderate neuromuscular blockade in patients during renal transplantation
A trial monitoring the immune effects in 24 people with 4 different doses (1 gram per day, 2 grams per day, 4 grams per day, 8 grams per day) of a natural plant-based protein hydrolysate.
Adalimumab is a recombinant monoclonal antibody (IgG1 subclass) against human TNF-α (Tumor Necrosis Factor-alpha). It is an immunosuppressive medication predominantly used to treat rheumatoid arthritis autoimmune disease. It is also used for the treatment of psoriatic arthritis, ankylosing spondylitis, and Crohn's disease etc. Adalimumab binds specifically to TNF-α and blocks its general cytokine effects, thereby reducing TNF-induced inflammation and halting tissue destruction. Adalimumab was approved for medical use in the United States in 2002. It is on the World Health Organization's List of Essential Medicines. It is available as a biosimilar medication. In 2017, it was the 169th most commonly prescribed medication in the United States, with more than three million prescriptions. Adalimumab is an expensive product which is indicated in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, etc. Each patient will be provided the study drug free of cost in this study which will benefit them immensely. The advent of therapeutic monoclonal antibodies has given a major boost to the treatment of individuals suffering from autoimmune disorders, including rheumatoid arthritis. Adalimumab is one such therapeutic monoclonal antibody used for treatment of rheumatoid arthritis marketed with brand name Humira by Abbvie Ltd. (USA) was the only adalimumab biosimilar available for patients in Bangladesh until recently. Incepta Pharmaceuticals Ltd. Bangladesh has introduced Bangladesh's first locally manufactured adalimumab biosimilar Advixa that is available at a fraction of Humira's cost. This study aims to evaluate the pharmacokinetics, safety and efficacy of the Adalimumab biosimilar (Advixa) in comparison to Adalimumab (Humira) as reference. The biosimilar Advixa being a local product will a cost-effective alternative to imported drugs currently available in the market. Objectives of the Protocol General objectives- 1. To assess the Pharmacokinetic between Test Product (A): Adalimumab (Advixa) 40 mg/ 0.4 ml of Incepta Pharmaceuticals Ltd of Bangladesh and the corresponding Reference Product (B): Humira 40 mg/ 0.4ml of Abbvie Ltd in normal, healthy, adult, human subjects in a Parallel group study. 2. To evaluate the safety between two products. 3. To assess efficacy, tolerability and safety of biosimilar adalimumab (Advixa, Incepta) in compared with reference adalimumab (Humira, AbbVie) in patients with moderate to severe rheumatoid arthritis (RA). Specific objectives- 1. Pharmacokinetic (PK) Parameters: For Cmax and AUC0-t the 90% confidence interval for the ratio of the test and reference products should be contained within the acceptance interval of 80.00-125.00%. 2. Safety assessment: Evaluation and comparison between references vs. test drug in terms of safety end point. 3. Efficacy assessment: The primary endpoints will be - 1. Proportion of patients with an ACR20 response in both the treatment groups at week 12. 2. Evaluation and comparison of safety between references vs. test drug. The secondary endpoints will be - 1. Change in Disease Activity Score of 28 joints - CRP (DAS28-CRP), 2. Proportion of patient with an ACR50 response and 3. Proportion of patients with an ACR70 response in both the treatment groups at week 12.
This is a Phase 1, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients with Advanced Solid Tumors. The study will include a dose escalation phase (Part 1) and a dose expansion phase (Part 2). Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12 hours) in continuous 28-day cycles.
This trial will be a Phase I Open Label, Placebo-controlled Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Natrunix via Subcutaneous Injection in Healthy Subjects. The target enrollment is 8 healthy subjects per cohort (including six for Natrunix and two for placebo). Three cohorts for a total of 24 healthy volunteers.
Evaluation of the pharmacokinetics of levosimendan and its metabolites in intensive care patients with normal, reduced and dialysis supported renal function.
A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days.