Bioequivalence of Pomalidomide Capsules in Fasting and Fed States in Healthy Male Volunteers: A Randomized, Open, Single‐Dose, Biperiodic, Double‐Crossover Study
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1173
Abstract: This study evaluated the safety, pharmacokinetic parameters, and bioequivalence (BE) of pomalidomide (POM) capsules (specification: 4 mg) acquired from 2 sponsors (test [T] and reference [R]), under fasting and fed conditions. A single‐center, randomized, open‐label,… read more here.
Keywords: single dose; fasting fed; fed states; concentration ... See more keywords
Effects of Food on the Pharmacokinetics and Safety of a Novel c-Met Inhibitor SPH3348: A Single-Center, Randomized, Open-Label, Single-Dose, 2-Period, 2-Sequence Crossover Study.
Sign Up to like & getrecommendations! Published in 2025 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1590
Abstract: This randomized, open-label, 2-period crossover study evaluated food effects on SPH3348 pharmacokinetics (PK) and safety in 16 healthy participants receiving a single 480-mg dose under fasting and high-fat fed conditions. PK profiling involved serial blood… read more here.
Keywords: food; randomized open; safety; study ... See more keywords
Efficacy of Favipiravir in treatment of mild & moderate COVID-19 infection in Nepal: a multi-center, randomized, open-labelled, phase III clinical trial
Sign Up to like & getrecommendations! Published in 2022 at "International Journal of Infectious Diseases"
DOI: 10.1016/j.ijid.2021.12.109
Abstract: Purpose To study tolerability and outcome of oral favipiravir treatment among COVID-19 patients in Nepal. Methods & Materials In this multi-centered randomized, open-labelled phase III clinical trial, we enrolled 18-80 years old, RT-PCR confirmed patients… read more here.
Keywords: randomized open; labelled phase; infection; mild moderate ... See more keywords
A Randomized Open-Label Phase III Trial Evaluating the Addition of Denosumab to Standard First-Line Treatment in Advanced NSCLC: The European Thoracic Oncology Platform (ETOP) and European Organisation for Research and Treatment of Cancer (EORTC) SPLENDOUR Trial
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Thoracic Oncology"
DOI: 10.1016/j.jtho.2020.06.011
Abstract: Abstract Introduction Receptor activator of NF-kB ligand stimulates NF-kB–dependent cell signaling and acts as the primary signal for bone resorption. Retrospective analysis of a large trial comparing denosumab versus zoledronic acid in bone metastatic solid… read more here.
Keywords: chemotherapy; treatment; oncology; trial ... See more keywords
Topical tacrolimus and corticosteroids in childhood moderate-to-severe atopic dermatitis with impact on airways: A long-term randomized open-label study.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical and experimental dermatology"
DOI: 10.1093/ced/llad098
Abstract: BACKGROUND Childhood atopic dermatitis (AD) is often followed by other atopic comorbidities like asthma. OBJECTIVE To compare effectiveness of topical tacrolimus (TAC) and topical corticosteroids (TCSs) and their impact on airway inflammation and bronchial hyperresponsiveness… read more here.
Keywords: topical tacrolimus; moderate severe; atopic dermatitis; difference ... See more keywords
A Randomized, Open-label, Two-period Crossover Bridging Study on Fuzuloparib Capsules of Different Specifications in Healthy Chinese Volunteers.
Sign Up to like & getrecommendations! Published in 2021 at "British journal of clinical pharmacology"
DOI: 10.1111/bcp.15035
Abstract: INTRODUCTION Fuzuloparib, also known as fluzoparib or SHR3162, is a poly ADP-ribose polymerase (PARP) inhibitor developed for the treatment of malignant tumor. Three specifications of fuzuloparib capsules (10mg, 40mg and 100mg) were originally developed for… read more here.
Keywords: randomized open; fuzuloparib capsules; period; study ... See more keywords
Impact of Insulin Tregopil and Its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open‐Label, Placebo‐Controlled, Crossover Study
Sign Up to like & getrecommendations! Published in 2019 at "Clinical and Translational Science"
DOI: 10.1111/cts.12609
Abstract: Oral insulin tregopil (IN‐105; a new drug under development) may be coadministered with oral antidiabetic drugs, such as metformin in patients with type 2 diabetes mellitus for optimal glycemic control. IN‐105 has sodium caprate excipient,… read more here.
Keywords: randomized open; permeation enhancer; study; healthy volunteers ... See more keywords
Bioavailability of Lumefantrine Is Significantly Enhanced with a Novel Formulation Approach, an Outcome from a Randomized, Open-Label Pharmacokinetic Study in Healthy Volunteers
Sign Up to like & getrecommendations! Published in 2017 at "Antimicrobial Agents and Chemotherapy"
DOI: 10.1128/aac.00868-17
Abstract: ABSTRACT The artemether-lumefantrine combination requires food intake for the optimal absorption of lumefantrine. In an attempt to enhance the bioavailability of lumefantrine, new solid dispersion formulations (SDF) were developed, and the pharmacokinetics of two SDF… read more here.
Keywords: randomized open; bioavailability; study; formulation ... See more keywords
Entecavir versus tenofovir for prevention of hepatitis B virus-associated hepatocellular carcinoma after curative resection: study protocol for a randomized, open-label trial
Sign Up to like & getrecommendations! Published in 2024 at "Trials"
DOI: 10.1186/s13063-023-07742-x
Abstract: Background Entecavir and tenofovir disoproxil fumarate (TDF) are standard first-line treatments to prevent viral reactivation and hepatocellular carcinoma (HCC) in individuals chronically infected with the hepatitis B virus (HBV), but the long-term efficacy of the… read more here.
Keywords: hepatitis virus; trial; hepatocellular carcinoma; curative resection ... See more keywords
Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2018.36.15_suppl.e17519
Abstract: e17519Background: The multi-center, randomized, open-lable, phaseⅢ trial discussed in the present study was performed to compare clinical outcomes of nedaplatin (NDP) plus paclitaxel, and carboplat... read more here.
Keywords: randomized open; multi center; center randomized; paclitaxel plus ... See more keywords
A phase 3, randomized, open-label study of nivolumab combined with cabozantinib vs sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC; CheckMate 9ER).
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2018.36.15_suppl.tps4598
Abstract: TPS4598Background: Over the past decade, treatment options for advanced RCC have evolved to include multiple agents targeting the vascular endothelial growth factor (VEGF) pathway. In addition, the... read more here.
Keywords: randomized open; phase randomized; nivolumab combined; open label ... See more keywords