Articles with "pharmacokinetics safety" as a keyword



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Pharmacokinetics and Safety of Vibegron 75 mg Administered as an Intact or Crushed Tablet in Healthy Adults

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Published in 2022 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.1169

Abstract: Oral pharmacotherapy for overactive bladder, a condition that increases with age, includes anticholinergics and β3‐adrenergic receptor agonists. Older adults, including those with dysphagia, may have difficulty swallowing tablets. In this phase 1 study in healthy… read more here.

Keywords: vibegron; pharmacokinetics safety; tablet; healthy adults ... See more keywords
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Pharmacokinetics and Safety of Risperidone Subcutaneous Implants in Stable Patients With Schizophrenia

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Published in 2018 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.428

Abstract: A subcutaneous risperidone implant (RI) formulation was developed to improve medication adherence in schizophrenia. Two phase 1 studies were conducted to evaluate the pharmacokinetics of RI in adult patients with schizophrenia. In study 1, all… read more here.

Keywords: concentration; pharmacokinetics safety; oral risperidone; patients schizophrenia ... See more keywords
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Systemic Pharmacokinetics, Safety, and Preliminary Efficacy of Topical AhR Agonist Tapinarof: Results of a Phase 1 Study

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Published in 2018 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.439

Abstract: Tapinarof cream is a novel topical nonsteroidal agent that represents a unique class of anti‐inflammatory molecules targeting the aryl hydrocarbon receptor. Study 201851 was an open‐label, 2‐cohort sequential study that assessed the systemic pharmacokinetics, safety,… read more here.

Keywords: tapinarof; efficacy; pharmacokinetics safety; systemic pharmacokinetics ... See more keywords
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Evaluation of Pharmacokinetics, Safety, and Drug‐Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults

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Published in 2021 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.925

Abstract: Intravenous (IV) edaravone is approved as an amyotrophic lateral sclerosis (ALS) treatment. Because IV administration places a burden on patients, development of orally administered ALS treatments is needed. Therefore, 2 phase 1 studies of oral… read more here.

Keywords: formulation; edaravone healthy; drug; edaravone ... See more keywords
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Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States

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Published in 2021 at "Journal of the International AIDS Society"

DOI: 10.1002/jia2.25747

Abstract: Vaginal rings are a promising approach to provide a woman‐centred, long‐acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of… read more here.

Keywords: vaginal rings; phase pharmacokinetics; safety; pharmacokinetics safety ... See more keywords
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The effect of potent CYP2D6 inhibition on the pharmacokinetics and safety of deutetrabenazine in healthy volunteers.

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Published in 2021 at "European journal of clinical pharmacology"

DOI: 10.1007/s00228-021-03202-0

Abstract: PURPOSE Deutetrabenazine is a deuterated form of tetrabenazine with a confirmed lower rate of CYP2D6 metabolism of the active metabolites, α- and β-HTBZ. In this study, we assessed the effect of paroxetine, a potent CYP2D6… read more here.

Keywords: safety deutetrabenazine; safety; potent cyp2d6; effect ... See more keywords
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Pharmacokinetics and safety of rilpivirine in healthy Japanese subjects and exploration of ethnic sensitivity of rilpivirine pharmacokinetics with physiologically based pharmacokinetic model approach.

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Published in 2021 at "Drug metabolism and pharmacokinetics"

DOI: 10.1016/j.dmpk.2021.100422

Abstract: Rilpivirine is a non-nucleoside reverse transcriptase inhibitor, used for the treatment of human immunodeficiency virus type-1 infection. An open label study was conducted to investigate the pharmacokinetics (PK) and safety of a single oral dose… read more here.

Keywords: rilpivirine; physiologically based; model; pharmacokinetics safety ... See more keywords
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Cinnamaldehyde in diabetes: A review of pharmacology, pharmacokinetics and safety

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Published in 2017 at "Pharmacological Research"

DOI: 10.1016/j.phrs.2017.05.019

Abstract: &NA; Cinnamaldehyde, one of the active components derived from Cinnamon, has been used as a natural flavorant and fragrance agent in kitchen and industry. Emerging studies have been performed over the past decades to evaluate… read more here.

Keywords: diabetes review; cinnamaldehyde diabetes; safety; pharmacology ... See more keywords
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Pharmacokinetics and Safety of Mitragynine in Beagle Dogs.

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Published in 2020 at "Planta medica"

DOI: 10.1055/a-1212-5475

Abstract: Mitragynine is the most abundant psychoactive alkaloid derived from the leaves of Mitragyna speciosa (kratom), a tropical plant indigenous to regions of Southeast Asia. Mitragynine displays a moderate affinity to opioid receptors, and kratom is… read more here.

Keywords: mitragynine beagle; mitragynine; beagle dogs; safety mitragynine ... See more keywords
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Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study

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Published in 2019 at "Journal of Antimicrobial Chemotherapy"

DOI: 10.1093/jac/dkz497

Abstract: Abstract Objectives To investigate pharmacokinetics (PK) and safety (primary objectives) and efficacy (secondary objective) of the investigational monobactam/β-lactamase inhibitor combination aztreonam/avibactam in patients with complicated intra-abdominal infection (cIAI). Methods This Phase 2a open-label, multicentre study… read more here.

Keywords: safety; aztreonam avibactam; min; pharmacokinetics safety ... See more keywords
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A phase II study to evaluate the pharmacokinetics, safety, and tolerability of Risperidone ISM multiple intramuscular injections once every 4 weeks in patients with schizophrenia

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Published in 2018 at "International Clinical Psychopharmacology"

DOI: 10.1097/yic.0000000000000203

Abstract: This study characterized the pharmacokinetics, safety, and tolerability of Risperidone ISM, a new long-acting intramuscular formulation, for monthly administration without oral supplementation. Patients with schizophrenia received multiple intramuscular injections of 75 mg in the gluteal or… read more here.

Keywords: risperidone ism; study; intramuscular injections; multiple intramuscular ... See more keywords