Similar Pharmacokinetics and Pharmacodynamics of Biosimilar SAR342434 Insulin Lispro and Japan‐Approved Humalog Insulin Lispro in Healthy Japanese Subjects
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DOI: 10.1002/cpdd.1068
Abstract: This phase 1 study compared the pharmacokinetic (PK) and glucose pharmacodynamic (PD) characteristics of biosimilar SAR342434 insulin lispro and Japan‐reference Humalog insulin lispro. This was a randomized, double‐blind, 2‐period, crossover study. Thirty‐six healthy Japanese male… read more here.
Keywords: time; humalog insulin; concentration; insulin lispro ... See more keywords
Pharmacokinetic, Safety, and Tolerability Evaluations of Gepotidacin (GSK2140944) in Healthy Japanese Participants
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DOI: 10.1002/cpdd.1192
Abstract: Gepotidacin is a novel, bactericidal, first‐in‐class triazaacenaphthylene antibiotic in late‐phase development for uncomplicated urinary tract infection and uncomplicated urogenital gonorrhea. Two clinical studies were conducted to assess the pharmacokinetics (PK) and interethnic comparisons of oral… read more here.
Keywords: healthy japanese; tolerability; pharmacokinetic safety; tolerability evaluations ... See more keywords
Bioequivalence Study of Ezetimibe Tablets After a Single Oral Dose of 10 mg in Healthy Japanese Subjects Under Fasting Conditions.
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DOI: 10.1002/cpdd.1245
Abstract: This study compared the pharmacokinetic and safety profiles between a new generic and a branded reference product of 10-mg ezetimibe (EZE) tablets in 24 healthy Japanese male volunteers under fasting conditions, obtaining sufficient evidence for… read more here.
Keywords: reference; fasting conditions; concentration; bioequivalence ... See more keywords
Ataluren Pharmacokinetics in Healthy Japanese and Caucasian Subjects
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DOI: 10.1002/cpdd.645
Abstract: To evaluate the potential for ethnicity‐related differences in ataluren pharmacokinetics (PK) and safety, a phase 1 single‐dose study was conducted in 48 healthy (24 Japanese and 24 Caucasian subjects), nonsmoking male volunteers who were equally… read more here.
Keywords: ataluren pharmacokinetics; pharmacology; japanese caucasian; healthy japanese ... See more keywords
A Phase 1, Randomized, Placebo‐Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men
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DOI: 10.1002/cpdd.775
Abstract: Tezepelumab, a human immunoglobulin G2 monoclonal antibody against thymic stromal lymphopoietin, is currently under clinical development for the treatment of severe, uncontrolled asthma. This phase 1, randomized, placebo‐controlled, single‐ascending‐dose study assessed the safety, tolerability, pharmacokinetics,… read more here.
Keywords: placebo; safety; phase randomized; healthy japanese ... See more keywords
Serum gamma-glutamyltransferase is inversely associated with dietary total and coffee-derived polyphenol intakes in apparently healthy Japanese men
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DOI: 10.1007/s00394-017-1549-1
Abstract: PurposeSerum γ-glutamyltransferase (GGT) has been proposed as a marker of oxidative stress. Here, we examined the association between serum GGT and the dietary intake of polyphenols, which have antioxidant properties.MethodsA cross-sectional survey including 7960 apparently… read more here.
Keywords: polyphenol intake; ggt; inversely associated; apparently healthy ... See more keywords
Pharmacokinetics, Pharmacodynamics, and Safety of the Novel Calcimimetic Agent Evocalcet in Healthy Japanese Subjects: First-in-Human Phase I Study
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DOI: 10.1007/s40261-018-0687-4
Abstract: Background and ObjectivesEvocalcet is a novel calcimimetic agent with potential to improve the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. This study aimed to determine the pharmacokinetics, pharmacodynamics, and safety of evocalcet… read more here.
Keywords: evocalcet healthy; evocalcet; safety; study ... See more keywords
Safety and tolerability of medicinal parasite ova (Trichuris suis) in healthy Japanese volunteers: A randomized, double-blind, placebo-controlled trial.
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DOI: 10.1016/j.parint.2021.102441
Abstract: BACKGROUND Trichuris suis ova (TSO), with the potential to modulate the human immune system, have been tested for therapeutic application in autoimmune and allergic diseases such as inflammatory bowel disease (IBD). Previous clinical studies were… read more here.
Keywords: trichuris suis; trial; safety tolerability; period ... See more keywords
Plasma Lipidomics of Healthy Japanese Adults Reveals Gender- and Age-Related Differences.
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DOI: 10.1016/j.xphs.2017.05.002
Abstract: Lipid metabolites in the blood are expected to be biomarker candidates to reflect disease states and responses to therapeutic drugs. However, their profiles are influenced by subject background, which may lead to confounding results. This… read more here.
Keywords: age; biomarker; associated differences; japanese adults ... See more keywords
Associations Between the Triglyceride to High-Density Lipoprotein Cholesterol Ratio and Metabolic Syndrome, Insulin Resistance, and Lifestyle Habits in Healthy Japanese.
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DOI: 10.1089/met.2019.0123
Abstract: Background: The triglyceride (TG)/high-density lipoprotein cholesterol (HDL-C) ratio is related to insulin resistance (IR). However, little information is available on whether TG/HDL-C is associated with IR and components of metabolic syndrome (MetS) and how lifestyle… read more here.
Keywords: lifestyle habits; ratio; hdl; men women ... See more keywords
Reference interval for the disc-macula distance to disc diameter ratio in a large population of healthy Japanese adults
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DOI: 10.1097/md.0000000000006613
Abstract: Abstract This study presents the calculated reference interval for the disc-to-macula distance to disc diameter ratio (DM:DD) based on a large population of healthy Japanese adults. A total of 308 consecutive, healthy Japanese adults were… read more here.
Keywords: reference interval; japanese adults; large population; healthy japanese ... See more keywords