Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial
Sign Up to like & getrecommendations! Published in 2017 at "JAMA Neurology"
DOI: 10.1001/jamaneurol.2016.4703
Abstract: Importance Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic… read more here.
Keywords: phase; opicapone; treatment; time ... See more keywords
Investigating Potential Bias in Patient-Reported Outcomes in Open-label Cancer Trials.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA oncology"
DOI: 10.1001/jamaoncol.2018.6205
Abstract: Recent legislative efforts such as the 21st Century Cures Act have emphasized capturing and communicating the patient experience. Patient-reported outcome (PRO) assessments are one method to measure symptoms, function, and health-related quality of life. In… read more here.
Keywords: open label; cancer trials; cancer; patient reported ... See more keywords
Parsaclisib for the treatment of primary autoimmune hemolytic anemia: Results from a phase 2, open‐label study
Sign Up to like & getrecommendations! Published in 2024 at "American Journal of Hematology"
DOI: 10.1002/ajh.27493
Abstract: Autoimmune hemolytic anemia (AIHA) is a group of acquired autoimmune disorders characterized by red blood cell hemolysis. In a phase 2, open‐label, multicenter study, adults with warm AIHA, cold agglutinin disease, or mixed‐type AIHA were… read more here.
Keywords: treatment; phase open; autoimmune hemolytic; hemolytic anemia ... See more keywords
Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study
Sign Up to like & getrecommendations! Published in 2021 at "Cancer Medicine"
DOI: 10.1002/cam4.4454
Abstract: An open‐label single‐arm phase 2 study was conducted to evaluate the role of levetiracetam as a sensitizer of concurrent chemoradiotherapy (CCRT) for patients with newly diagnosed glioblastoma. This study aimed to determine the survival benefit… read more here.
Keywords: study; levetiracetam sensitizer; glioblastoma; sensitizer concurrent ... See more keywords
Effect of Roxadustat on the Pharmacokinetics of Simvastatin, Rosuvastatin, and Atorvastatin in Healthy Subjects: Results From 3 Phase 1, Open‐Label, 1‐Sequence, Crossover Studies
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1076
Abstract: Roxadustat inhibits breast cancer resistance protein and organic anion transporting polypeptide 1B1, which can affect coadministered statin concentrations. Three open‐label, 1‐sequence crossover phase 1 studies in healthy subjects were conducted to assess effects from steady‐state… read more here.
Keywords: roxadustat; label sequence; sequence crossover; atorvastatin ... See more keywords
Pharmacokinetics and Bioequivalence of 2 Azithromycin Tablet Formulations: A Randomized, Open‐Label, 2‐Stage Crossover Study in Healthy Volunteers
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1098
Abstract: The current study aimed to assess the bioequivalence of a new branded azithromycin with the reference formulation. An open‐label, randomized, 2‐stage, crossover study design was implemented involving 77 healthy volunteers under fasting conditions. Each volunteer… read more here.
Keywords: reference; crossover study; bioequivalence; open label ... See more keywords
Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1244
Abstract: Rimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist (gepant) with demonstrated efficacy and safety in the acute and preventive treatment of migraine. Here, we report the pharmacokinetics and safety of a single 75-mg oral… read more here.
Keywords: label single; rimegepant subjects; hepatic impairment; impairment ... See more keywords
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Zanubrutinib with Rifabutin in Healthy Volunteers.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1250
Abstract: Zanubrutinib is a second-generation Bruton tyrosine kinase inhibitor that is primarily metabolized by CYP3A enzymes. Previous drug-drug interaction (DDI) studies have demonstrated that co-administration of zanubrutinib with rifampin, a strong CYP3A inducer, reduces zanubrutinib plasma… read more here.
Keywords: open label; zanubrutinib; drug drug; phase open ... See more keywords
At‐Home Self‐Collection of Pharmacokinetic Data: Design and Results From a Phase 1 Open‐Label Feasibility Trial
Sign Up to like & getrecommendations! Published in 2024 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1495
Abstract: Pharmacokinetic (PK) studies pose unique technical challenges. We present the design of a Phase 1, open‐label, fixed‐sequence, PK trial that aimed to compare the timing accuracy of participant‐ versus staff‐collected data, and we provide safety… read more here.
Keywords: ecgs vital; vital signs; phase open; blood ... 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
Pharmacokinetics and Bioequivalence of two Empagliflozin Tablet Formulations: Results From a Randomized, Open-Label, Crossover Study in Fasting Healthy Volunteers.
Sign Up to like & getrecommendations! Published in 2025 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1614
Abstract: This study aimed to assess the bioequivalence of a newly developed generic formulation of empagliflozin in comparison with the reference product. A total of 32 healthy adult volunteers participated in an open-label, randomized, balanced, two-treatment,… read more here.
Keywords: reference; bioequivalence; study; open label ... See more keywords