Advertisement

Topics

PubMed Journals Articles About "An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg" RSS

13:51 EDT 26th May 2018 | BioPortfolio

An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg articles that have been published worldwide.

More Information about "An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg" on BioPortfolio

We have published hundreds of An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg news stories on BioPortfolio along with dozens of An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg Clinical Trials and PubMed Articles about An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg Companies in our database. You can also find out about relevant An Open-Label Evaluation Of The Dose Proportionality Of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg Drugs and Medications on this site too.

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

Evaluation of the Relative Abuse of an OROS® Extended-release Hydromorphone HCI Product: Results from three Post-market Surveillance Studies.

Formulating prescription opioids to limit abuse remains a priority. OROS® extended-release (ER) hydromorphone HCl (EXALGO®) may have low abuse potential. Three post-marketing studies of the relative abuse liability of OROS hydromorphone ER were conducted.


Content uniformity of quartered hydrocortisone tablets in comparison with mini-tablets for paediatric dosing.

Children requiring cortisol replacement therapy are often prescribed hydrocortisone doses of 2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split commonly in an attempt to deliver the correct dose. This study aimed to determine the dose variation obtained from quartered hydrocortisone tablets when different operators performed the splitting procedure and to ascertain whether better uniformity could be attained from mini-tablets as an alternative formulati...

A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients.

Hydromorphone is a standard opioid analgesic for cancer pain that, prior to this study, was not approved in Japan, where options for opioid switching are limited. We aimed to investigate the efficacy and safety of hydromorphone (DS-7113b) immediate-release tablets in opioid-naïve cancer patients with moderate to severe cancer pain.


Effect of Crushing, Cutting into Half, or Grinding of Co-formulated Glecaprevir/Pibrentasvir Tablets on Pharmacokinetic Measurements in Healthy Subjects.

Glecaprevir (GLE) and pibrentasvir (PIB) are direct-acting antivirals coformulated as a combination tablet for once-daily treatment of chronic hepatitis C virus infection. The objective of this study was to evaluate the effect of different methods of tablet manipulations - cutting in half, grinding into powder, or crushing- on the bioavailability of GLE and PIB relative to whole film-coated bilayer tablets. This was a Phase 1, single-dose, open-label, randomized, five-period, nonfasting, crossover study in ...

Pharmacokinetics of single-dose sildenafil administered orally in clinically healthy dogs: Effect of feeding and dose proportionality.

Basic information related to the pharmacokinetics of sildenafil in dogs is scarce. This study aimed to describe the pharmacokinetic properties of oral sildenafil and determine the effect of feeding and dose proportionality. The effect of feeding on pharmacokinetics of sildenafil (1 mg/kg) was investigated using a crossover study with six dogs. In addition, the dose proportionality of sildenafil ranging 1-4 mg/kg was evaluated using five dogs in the fasted states. The plasma concentrations of sildenafil we...

Prescribing Placebos: An Experimental Examination of the Role of Dose, Expectancies, and Adherence in Open-Label Placebo Effects.

Recent evidence indicates that placebo effects can occur even when patients know that they are taking a placebo, termed the open-label placebo effect.

Safety of single dose primaquine in G6PD-deficient and G6PD-normal males in Mali without malaria: an open-label, phase 1, dose-adjustment trial.

The World Health Organization recommendation on the use of single low-dose primaquine (SLD-PQ) to reduce Plasmodium falciparum malaria transmission requires more safety data.

Discordant Umbilical Cord Drug Testing Results in Monozygotic Twins.

Our laboratory received segments of umbilical cord that originated from identical twins for routine toxicology analysis. The specimens were analyzed multiple times by liquid chromatography tandem mass spectrometry. The umbilical cord from newborn #1 was positive for hydromorphone only (1.06 ng/g), and the umbilical cord from newborn #2 was positive for hydromorphone (0.81 ng/g) and benzoylecgonine (5.41 ng/g). The hydromorphone results are consistent with maternal administration of hydromorphone; however, t...

Pharmacokinetic Interaction between Faldaprevir and Cyclosporine or Tacrolimus in Healthy Subjects: A Prospective, Open-Label, Fixed-Sequence, Cross-Over Study.

Faldaprevir (FDV) is a potent, orally administered inhibitor of hepatitis C virus. In this single-centre, open-label, fixed-sequence, cross-over study of 32 healthy adult male and female volunteers, subjects received either a single dose of cyclosporine (CsA) 50 mg (N=16) or tacrolimus (TAC) 0.5 mg (N=16), followed by a washout of at least 14 days. Each subject then received a loading dose of FDV 240 mg followed by 120 mg FDV once daily for 6 days. FDV 120 mg was then co-administered with an additional sing...

Why do open-label placebos work? A randomized controlled trial of an open-label placebo induction with and without extended information about the placebo effect in allergic rhinitis.

Several studies demonstrated that placebo treatment may have a significant impact on many different symptoms. While in the traditional view concealment of the placebo is essential, recent studies report intriguing evidence that placebos may work even without deception. For example, it has been demonstrated that open-label placebos can improve symptoms in allergic rhinitis. However, the mechanisms of how placebos without concealment work remain unknown.

Phase I study of taselisib in Japanese patients with advanced solid tumors or hormone receptor-positive advanced breast cancer.

Taselisib is a potent and selective phosphatidylinositide 3-kinase (PI3K) inhibitor. This paper reports the first study of taselisib administration in Japanese patients. The aim of this two-stage, phase I, multicenter, open-label, dose-escalation study was to evaluate the safety, pharmacokinetics, and preliminary efficacy of taselisib as monotherapy in Japanese patients with advanced solid tumors (Stage 1), and as part of combination therapy in Japanese patients with hormone receptor (HR)-positive locally a...

Statistical Controversies in Clinical Research: Limitations of open-label studies assessing antiangiogenic therapies with regard to evaluation of vascular adverse drug events. A meta-analysis.

Previous meta-analyses have shown paradoxical increased risk of bleeding and thrombotic events in patients receiving antiangiogenics (AA) that may be simply explained by the studies design included. By a meta-epidemiological approach, we aim to investigate the impact of double-blind (DB) and open-label study designs on the risks of bleeding, venous thrombotic events (VTE) and arterial thrombotic events (ATE) in cancer patients treated with AA.

Bioavailability and Pharmacokinetics of TRPV1 Antagonist Mavatrep (JNJ-39439335) Tablet and Capsule Formulations in Healthy Men: Two Open-Label, Crossover, Single-Dose Phase 1 Studies.

To improve room temperature stability and oral bioavailability of mavatrep (JNJ-39439335, a transient receptor potential vanilloid subtype-1 antagonist), various formulations were initially developed and evaluated in 2 phase 1 open-label, randomized, 3-way crossover studies in healthy participants. Study 1 evaluated 2 new overencapsulated tablet formulations (formulations B and C) relative to an overencapsulated early tablet formulation (formulation A), using mavatrep HCl salt form. Because these tablets we...

An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer.

This randomized, open-label, active-controlled study investigated the safety and efficacy of three doses of Rolontis (eflapegrastim), a novel, long-acting myeloid growth factor, versus pegfilgrastim in breast cancer patients being treated with docetaxel and cyclophosphamide (TC). The primary efficacy endpoint was duration of severe neutropenia (DSN) during the first cycle of treatment. Patients who were candidates for adjuvant/neoadjuvant TC chemotherapy were eligible for participation. TC was administered ...

Alirocumab in high-risk patients: Observations from the open-label expanded use program.

The alirocumab expanded use program provided open-label access to alirocumab before its commercial availability to patients with severe hypercholesterolemia not controlled with maximally tolerated doses of standard-of-care lipid-lowering therapy.

An Open-Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics.

Pomalidomide is an immunomodulatory drug and the dosage of 4 mg per day taken orally on days 1-21 of repeated 28-day cycles has been approved in the European Union and United States to treat patients with relapsed/refractory multiple myeloma. Because pomalidomide is extensively metabolized prior to excretion, a total of 32 subjects (8 healthy subjects in group 1; 8 subjects with severe hepatic impairment in group 2; 8 subjects with moderate hepatic impairment in group 3; and 8 subjects with mild hepatic i...

Open-label, cluster randomised controlled trial and economic evaluation of a brief letter from a GP on unscheduled medical contacts associated with the start of the school year: the PLEASANT trial.

Asthma is seasonal with peaks in exacerbation rates in school-age children associated with the return to school following the summer vacation. A drop in prescription collection in August is associated with an increase in the number of unscheduled contacts after the school return.

Tofacitinib in patients with moderate to severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study.

Tofacitinib is an oral Janus kinase inhibitor. Final safety and efficacy data from an open-label extension study of tofacitinib in psoriasis are reported.

Genetic imaging study with Tc- TRODAT-1 SPECT in adolescents with ADHD using OROS-methylphenidate.

To examine theeffects on the brain of 2-month treatment withamethylphenidate extended-release formulation (OROS-MPH) using [Tc-] TRODAT-1SPECT in a sample of treatment-naïve adolescents with Attention Deficit/Hyperactivity Disorder (ADHD). In addition, to assess whether risk alleles (homozygosity for 10-repeat allele at the DAT1 gene were associated with alterations in striatal DAT availability.

Patiromer Lowers Serum Potassium When Taken without Food: Comparison to Dosing with Food from an Open-Label, Randomized, Parallel Group Hyperkalemia Study.

Patiromer is a sodium-free, nonabsorbed, potassium binder approved for treatment of hyperkalemia. This open-label study compares the efficacy and safety of patiromer administered without food versus with food.

Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies.

Teneligliptin, an antihyperglycemic agent belonging to the dipeptidyl peptidase-4 inhibitor class, is usually prescribed at a dose of 20 mg/day. In Japan, the dose can be increased to 40 mg/day if needed. We examined the treatment response when the teneligliptin dose was increased from 20 to 40 mg in a post hoc pooled analysis of data from two 52-week, open-label, phase III clinical trials of teneligliptin 20-40 mg/day as monotherapy or combination treatment in Japanese patients with type 2 diabetes.

Simultaneous Quantitation of Amlodipine Besylate and Olmesartan Medoxomil in Fixed-Dose Combination Tablets: HPLC-DAD Versus UHPLC-DAD.

Association of amlodipine besylate and olmesartan medoxomil in fixed-dose combination tablets is effective, safe and well tolerated for the treatment of hypertension. The aim of this study was to optimize and validate a novel and fast UHPLC-DAD method for simultaneous quantification of these antihypertensive drugs in tablets, using a transfer procedure from a conventional HPLC-DAD method. The HPLC separation was carried out using a C18 column (150 × 4.6 mm2; 5 μm) and a mobile phase composed of acetonitri...

The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non-Small-Cell Lung Cancer and in Healthy Volunteers.

Two phase 1, open-label studies assessed the impact of food or gastric pH modification (omeprazole) on the exposure and safety/tolerability of osimertinib and its metabolites. The food effect study was an open-label, 2-period crossover study in patients with advanced non-small-cell lung cancer, randomized into 2 treatment sequences: single-dose osimertinib 80 mg in a fed then fasted state or fasted then fed. The gastric pH study was an open-label, 2-period fixed sequence study assessing the effect of omepr...

A sensitive LC-MS/MS method for simultaneous determination of cabozantinib and its metabolite cabozantinib N-oxide in rat plasma and its application in a pharmacokinetic study.

Cabozantinib (CBZ) could be used for the treatment of progressive, metastatic medullary thyroid cancer. Its major oxidative metabolite is cabozantinib N-oxide (CBN) which contains a structural alert associated with mutagenicity, yet the pharmacokinetics study lacks the simultaneous investigation of CBN and dose proportionality. In current study a simple LC-MS/MS method was developed and validated for the simultaneous estimation and pharmacokinetic investigation of CBZ and CBN in rat plasma. The analytes wer...

Pharmacokinetic Interaction Between Fingolimod and Carbamazepine in Healthy Subjects.

This open-label, single-sequence study in healthy subjects investigated the effects of steady-state carbamazepine on the pharmacokinetic (PK) profile of a single 2-mg dose of fingolimod. In period 1, a single oral dose of fingolimod 2 mg (day 1) was followed by PK and safety assessments up to 36 days. In period 2, carbamazepine was administered in flexible, up-titrated doses (600 mg twice daily maximum) for 49 days. Fingolimod was administered on day 35, followed by a study completion evaluation (day 71...


Advertisement
Quick Search
Advertisement
Advertisement