Articles with "chinese subjects" as a keyword



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Pharmacokinetics and Bioequivalence of a Generic and a Branded Pazopanib Tablet in Healthy Chinese Subjects

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Published in 2022 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.1096

Abstract: This study aimed to evaluate the bioequivalence of two pazopanib tablet formulations in healthy Chinese subjects. A randomized, open‐label, single‐dose, two‐period, two‐sequence, crossover study was conducted under fasting conditions. A total of 32 eligible subjects… read more here.

Keywords: pazopanib tablet; chinese subjects; tablet; generic branded ... See more keywords
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Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects

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Published in 2022 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.1159

Abstract: Eldecalcitol is a novel active vitamin D3 1,25(OH)2D3 derivative used in the treatment of osteoporosis. To investigate and compare the pharmacokinetic and bioequivalent profiles of two eldecalcitol soft capsule formulations at a single dose of… read more here.

Keywords: chinese subjects; fed conditions; eldecalcitol soft; soft capsules ... See more keywords
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A Single‐dose, Two‐Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects

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Published in 2023 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.1187

Abstract: Liraglutide, a glucagon‐like peptide 1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The original liraglutide products are costly, which limits patient… read more here.

Keywords: single dose; chinese subjects; liraglutide formulations; bioequivalence ... See more keywords
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Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects

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Published in 2023 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.1212

Abstract: A pharmacokinetic (PK) study and a bioequivalence (BE) study were conducted to investigate the PK characteristics and safety of lubiprostone in healthy Chinese subjects and to evaluate the BE between the test and the reference… read more here.

Keywords: single dose; state; chinese subjects; lubiprostone ... See more keywords
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Pharmacokinetic Profile of a Generic Formulation of Sofosbuvir and Its Metabolite GS‐331007 in Healthy Chinese Subjects

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Published in 2019 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.674

Abstract: Sofosbuvir is an NS5B nucleotide inhibitor for the treatment of hepatitis C viral infection. In this study the pharmacokinetics (PK) and safety of single and multiple doses of generic sofosbuvir were investigated in healthy Chinese… read more here.

Keywords: healthy chinese; chinese subjects; generic formulation; formulation sofosbuvir ... See more keywords
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Serum amylase activity altered by the ABO blood group system in Chinese subjects

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Published in 2019 at "Journal of Clinical Laboratory Analysis"

DOI: 10.1002/jcla.22883

Abstract: The underlying interactions between ABO blood group antigens and pancreatic exocrine tissue have been demonstrated, and serum amylase was synthesized by pancreatic ductal cells. Thus, we investigated the link between ABO blood type and serum… read more here.

Keywords: blood group; serum amylase; amylase activity; chinese subjects ... See more keywords
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Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Oral Doses of Tegoprazan in Healthy Chinese Subjects

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Published in 2020 at "Clinical Drug Investigation"

DOI: 10.1007/s40261-020-00986-4

Abstract: Background and Objectives Tegoprazan is one of the potassium-competitive acid blockers (P-CABs). It exhibits its anti-secretory effects by competitively and reversibly blocking the availability of K + of the H + , K + -ATPase.… read more here.

Keywords: healthy chinese; administration; safety; single ascending ... See more keywords
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Short-term Safety, Tolerability, and Pharmacokinetics of MRX-I, an Oxazolidinone Antibacterial Agent, in Healthy Chinese Subjects.

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Published in 2018 at "Clinical therapeutics"

DOI: 10.1016/j.clinthera.2017.12.017

Abstract: PURPOSE This study was designed to evaluate the safety and pharmacokinetic profiles of MRX-I tablet, an oxazolidinone antibacterial agent, in healthy Chinese subjects. METHODS The study was composed of 3 sequential periods. Period 1 was… read more here.

Keywords: healthy chinese; study; oxazolidinone antibacterial; chinese subjects ... See more keywords
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Pharmacokinetics, Tolerability, and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects.

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Published in 2018 at "Clinical therapeutics"

DOI: 10.1016/j.clinthera.2018.05.009

Abstract: PURPOSE The pharmacokinetic (PK) profile of the rotigotine transdermal patch is well characterized in Caucasian patients with Parkinson's disease (PD) but not in Chinese subjects. This article reports the PK variables, safety, and tolerability of… read more here.

Keywords: healthy chinese; unconjugated total; rotigotine healthy; rotigotine ... See more keywords
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Mitochondrial tRNA mutations in 887 Chinese Subjects with Hearing Loss.

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Published in 2020 at "Mitochondrion"

DOI: 10.1016/j.mito.2020.03.005

Abstract: Mutations in the mitochondrial tRNAs have been reported to be the important cause of hearing loss. However, only a few cases have been identified thus far and the prevalence of mitochondrial tRNA mutations in hearing-impaired… read more here.

Keywords: hearing loss; chinese subjects; mitochondrial trna; trna mutations ... See more keywords
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Safety and pharmacokinetics of a biosimilar of denosumab (KN012): Phase 1 and bioequivalence study in healthy Chinese subjects

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Published in 2020 at "Expert Opinion on Investigational Drugs"

DOI: 10.1080/13543784.2021.1863371

Abstract: ABSTRACT Background KN012 is a proposed biosimilar candidate for the reference drug denosumab, with the brand name Prolia®. This study explored the tolerance, variability, and pharmacokinetics (PK) of denosumab and its biosimilar in healthy Chinese… read more here.

Keywords: healthy chinese; denosumab; study; biosimilar denosumab ... See more keywords