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Showing "Open Label Evaluation Dose Proportionality OROS Hydromorphone Tablets" PubMed Articles 1–25 of 17,000+

Preparation and evaluation of non-effervescent gastroretentive tablets containing pregabalin for once-daily administration and dose proportional pharmacokinetics.

The main purpose of this study was to develop gastroretentive tablets with floating and swelling properties for once-daily administration of pregabalin. The non-effervescent floating and swelling tablets were prepared using wet granulation and compaction, which are widely used and easily accessible. All formulations showed sustained release patterns and maintained buoyancy for over 24 h. The amount of hydroxypropyl methylcellulose and crospovidone were found to be critical factors affecting in vitro dissolu...

Effect of Food on the Pharmacokinetics of Ertugliflozin and Its Fixed-Dose Combinations Ertugliflozin/Sitagliptin and Ertugliflozin/Metformin.

Ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, is approved in the United States and European Union for the treatment of type 2 diabetes in adults, both as monotherapy and as part of fixed-dose combination (FDC) therapies with either sitagliptin or immediate-release metformin. The effect of a standard, high-fat breakfast on the pharmacokinetics of the highest strengths of ertugliflozin monotherapy (15 mg), ertugliflozin/sitagliptin FDC (15-/100-mg), and ertugliflozin/metformin FDC (7.5-/1000...

Open-Label Single-Dose Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of Mirogabalin.

Mirogabalin is an αδ ligand being developed to treat neuropathic pain. A small fraction of mirogabalin is metabolized by the liver, where hepatic impairment may affect exposure. The objective of this phase I, open-label single-dose study was to determine if mild or moderate hepatic impairment alters the pharmacokinetics of mirogabalin.

An Open-Label, Randomized, Pivotal Bioequivalence Study of Oral Rolapitant.

Rolapitant, a selective and long-acting neurokinin-1 receptor antagonist, is approved in an oral formulation for prevention of delayed chemotherapy-induced nausea and vomiting in adults. This pivotal open-label, randomized, single-dose, multicenter, parallel-group study assessed the bioequivalence of a single oral dose of 180 mg of rolapitant administered in tablet (2 × 90-mg tablets) or capsule (4 × 45-mg capsules) form in healthy male and female subjects. Blood samples for pharmacokinetic analysis wer...

Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis.

To evaluate the safety and maintenance of efficacy with ABT-122, a bi-specific monoclonal antibody targeting TNF and IL-17A, in patients with RA or PsA in open-label, 24-week extensions [open-label extensions (OLEs)] of 12-week, randomized, double-blind studies.

Effect of l-theanine tablets in reducing stress-related emotional signs in cats: an open-label field study.

L-theanine is an aminoacid found in tea leaves which has relaxing effects in humans and animals. It is a structural analogue of glutamate which can bind glutamate receptors. Although the relaxing action of L-theanine has been shown in humans, laboratory animals and dogs, it has never been published in cats. The goal of this open-label, multicentre and prospective trial was to determine whether an L-theanine based oral supplement (Anxitane®, Virbac, France) could attenuate manifestations of stress in cats u...

Efficacy of low-dose daily versus alternate-day prednisolone in frequently relapsing nephrotic syndrome: an open-label randomized controlled trial.

While patients with frequently relapsing nephrotic syndrome (FRNS) are initially treated with long-term alternate-day prednisolone, relapses and adverse effects are common. In an open-label randomized controlled trial, we compared the efficacy of therapy with low-dose daily to standard alternate-day prednisolone in reducing relapse rates over 12-month follow-up.

Proportional dose of rapid-onset opioid in breakthrough cancer pain management: An open-label, multicenter study.

The management of breakthrough pain (BTP) in cancer patients is a challenge. It is clinically useful to evaluate the effectiveness of rapid-onset opioid at a starting dose in proportional to the background opioid regimen. This open-label, multicenter, noncomparative study aimed to assess the efficacy and safety of proportional doses of fentanyl buccal soluble film (FBSF) in patients with breakthrough cancer pain.

Open-Label, Crossover Study to Determine the Pharmacokinetics of Fluticasone Furoate and Batefenterol When Administered Alone, in Combination, or Concurrently.

The study aim was to investigate the pharmacokinetics of single high doses and repeated therapeutic doses of fluticasone furoate (FF) and batefenterol (BAT; a bifunctional muscarinic antagonist and β -agonist) administered in combination (BAT/FF) or as monotherapy. In this open-label, 6-period, crossover study of 48 subjects, the treatment sequences were (1) single high-dose BAT/FF 900/300 μg followed by repeated therapeutic doses of BAT/FF 300/100 μg (once daily for 7 days); (2) single high-dose BAT 900...

Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy.

To evaluate long-term tolerability, safety and efficacy of adjunctive perampanel in a Phase II, multicentre, open-label, dose-ascending Study 231 (NCT00849212) and its extension (Study 233; NCT00903786) in Japanese patients with refractory partial-onset seizures (POS), with/without secondarily generalised seizures.

Open-label Placebos for Wound Healing: A Randomized Controlled Trial.

Open-label placebos are a novel treatment option, in which participants take placebos with full knowledge that they do not contain active medicine. Open-label placebo treatments have been shown to result in patient-reported symptom improvements, but they have not been tested on objectively measurable physiological outcomes such as wound healing.

An Open-Label Discontinuation Trial of Long-Term, Off-Label Antipsychotic Medication in People With Intellectual Disability: Determinants of Success and Failure.

Although physicians are aware of the risks of prescribing long-term off-label antipsychotics in people with intellectual disability, attempts to discontinue often fail. This study aimed to identify potential determinants of successful and failed discontinuation. Long-term off-label antipsychotics were tapered in 14 weeks, with 12.5% of baseline dose every 2 weeks. Participants living in facilities offered by intellectual disability service providers, ≥6 years, with an IQ


Experimental nanodosimetry aims to develop a new concept of radiation quality, based on the correlation between initial features of particle tracks and late biological outcome. A direct proportionality has been observed between the cumulative probability of measuring at least k ionisations within a nanometric volume and inactivation cross sections at specific survival levels. Based on this proportionality, physical quantities which are measurable at the nanometre level can be used to estimate the alpha and ...

Exploration and preparation of a dose-flexible regulation system for levetiracetam tablets via novel semisolid extrusion (SSE) 3D printing.

Levetiracetam therapy is often associated with high levels of individual variation in the recommended dose required to achieve preferential treatment. Thus, a reliable and dynamic regulation system to accurately tailor dose is necessary. The main objective of this work was to explore and prepare a dose-flexible control system suitable for rapid release tablets equipped with high drug loading and a cylindrical model design. Semisolid extrusion 3D printing was utilized to fabricate a series of tablets of incr...

An Open-Label, Multicenter, Phase I, Dose Escalation Study with Phase II Expansion Cohort to Determine the Safety, Pharmacokinetics, and Preliminary Antitumor Activity of Intravenous TKM-080301 in Subjects with Advanced Hepatocellular Carcinoma.

TKM-080301 showed a favorable toxicity profile at the studied dose.TKM-080301 targeting PLK1 through small interfering RNA mechanism did not demonstrate improved overall survival in patients with advanced hepatocellular carcinoma compared with historical control. Preliminary antitumor activity as shown in this early-phase study does not support further evaluation as a single agent.

Comparative phase I randomized open-label pilot clinical trial of Gynophilus (Lcr regenerans) immediate release capsules versus slow release muco-adhesive tablets.

Gynophilus (Lcr regenerans) is a live biotherapeutic product (LBP) that contains the live biotherapeutic microorganism Lactobacillus rhamnosus Lcr35, which is indicated to restore vaginal health. The aim of the study was to compare the safety, ease of use, and compliance of two formulations (immediate release: IR capsule and slow release: SR muco-adhesive tablets) as well as the colonization of Lcr35 in healthy women. This phase I study (Comprigel) is a parallel, randomized, 4-arm, and open-label clinical t...

Trends in and predictors of hydromorphone administration in US emergency departments (2007-2014).

To examine recent trends in and predictors of hydromorphone administration in US emergency departments (EDs) compared with other opioids.

A phase I study of single-agent BEZ235 special delivery system sachet in Japanese patients with advanced solid tumors.

BEZ235 is a dual kinase inhibitor of phosphatidylinositol 3-kinase (PI3K) and mammalian target of rapamycin, which are key components of the PI3K pathway. This was an open-label, multicenter, dose-escalation, phase I study of single-agent BEZ235 in Japanese oncology patients to determine the maximum tolerated dose (MTD) of BEZ235 based on dose-limiting toxicities (DLTs).

Corrigendum to " An extra priming dose of hepatitis A vaccine to adult patients with rheumatoid arthritis and drug induced immunosuppression - A prospective, open-label, multi-center study" Trav. Med. Infect. Dis. 21, January-February 2018, 43-50.

A 52-Week Study of Dose-Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable Auto-injector.

This open-label, single-arm, dose-blinded, 52-week, registration-phase study evaluated the efficacy and safety of subcutaneous testosterone enanthate auto-injector (SCTE-AI) administered weekly to men with hypogonadism.

Effects of low-dose glucocorticoid prophylaxis on chronic GVHD and GVHD-free, relapse-free survival after haploidentical transplantation: long-term follow-up of a controlled, randomized open-label trial.

This long-term follow-up study evaluated the effects of corticosteroid prophylaxis on GVHD-free, relapse-free survival (GRFS) based on a controlled open-label randomized trial in which 228 allotransplant recipients were categorized as low-risk (N = 83, group A) or high-risk; patients at high-risk were randomly assigned to receive (N = 72, group B) or not receive (N = 73, group C) low-dose methylprednisolone prophylaxis. The cumulative incidences of chronic GVHD, relapse, NRM, LFS, OS, and GRFS w...

Epacadostat Plus Pembrolizumab in Patients With Advanced Solid Tumors: Phase I Results From a Multicenter, Open-Label Phase I/II Trial (ECHO-202/KEYNOTE-037).

Tumors may evade immunosurveillance through upregulation of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme. Epacadostat is a potent and highly selective IDO1 enzyme inhibitor. The open-label phase I/II ECHO-202/KEYNOTE-037 trial evaluated epacadostat plus pembrolizumab, a programmed death protein 1 inhibitor, in patients with advanced solid tumors. Phase I results on maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics are reported.

Placebos in the era of open label trials: An Update for clinicians.

Placebos have been used extensively by vast numbers of physicians, in a majority of clinical trials. Placebo effects involve behavioral, psychological and genetic factors, and have been subject to ethical controversies stemming from the use of deception in treating patients. The patient-physician encounter, endogenous pharmacological pathways, personality traits and genetic diversity have all been reported to be key players in placebo responses. In the last decade, a new methodological paradigm of placebo r...

Single Low Dose of Human Recombinant Antithrombin (Atryn®) Has no Impact on Endotoxin-induced Disseminated Intravascular Coagulation: An Experimental Randomized Open Label Controlled Study.

Antithrombin III physiological levels are decreased during septic shock, and supplementation therapy could therefore be beneficial.

Prolonged treatment with open-label pirfenidone in Hermansky-Pudlak syndrome pulmonary fibrosis.

Limited information is available regarding chronic treatment with pirfenidone, an anti-fibrotic drug. Effects of long-term open-label pirfenidone were evaluated in a small cohort with Hermansky-Pudlak syndrome (HPS), a rare autosomal recessive disorder with highly penetrant pulmonary fibrosis.

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