Abstract:
BACKGROUND:A novel potassium-competitive acid blocker, DWP14012, is in clinical development as a potential alternative to proton pump inhibitors for the treatment of acid-related diseases. AIMS:To evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of DWP14012 in humans. METHODS:A randomised, double-blind, double-dummy, placebo- and active-controlled, single- and multiple-ascending dose (SAD and MAD, respectively) study was conducted in healthy male subjects without Helicobacter pylori infection. Subjects randomly received a single oral dose of 10-320 mg DWP14012, esomeprazole (active comparator) or placebo in the SAD study (n = 72) and once daily doses of 20-160 mg DWP14012, esomeprazole or placebo for 7 days in the MAD study (n = 48; 8:2:2). Tolerability was evaluated using a microRNA-122 assay. Pharmacodynamics were evaluated through 24-hour gastric pH monitoring, and pharmacokinetics were evaluated plasma and urine DWP14012 concentrations. RESULTS:DWP14012 was generally well tolerated. The liver toxicity of DWP14012 was not higher than that of placebo after multiple oral administrations. DWP14012 showed rapid and sustained suppression of gastric acid secretion for 24 hours after dosing. Clear dose-response and exposure-response relationships were observed. Plasma concentrations of DWP14012 increased in a dose-proportional manner in the MAD study, whereas in the SAD study, DWP14012 did not significantly accumulate in the plasma. CONCLUSIONS:DWP14012 was well tolerated, and showed a rapid and long-lasting gastric acid suppression effect in healthy subjects. These results justify further investigation of DWP14012 in patients with acid-related disorders.
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Sunwoo J,Oh J,Moon SJ,Ji SC,Lee SH,Yu KS,Kim HS,Lee A,Jang IJdoi
10.1111/apt.14818subject
Has Abstractpub_date
2018-07-01 00:00:00pages
206-218issue
2eissn
0269-2813issn
1365-2036journal_volume
48pub_type
杂志文章,随机对照试验abstract:BACKGROUND:Abnormal gall-bladder motility has been reported in diabetics. The objective was to evaluate the effect of chronic D2-dopamine receptor inhibition on gall-bladder emptying in diabetic patients. METHODS:Under double-blind placebo-controlled conditions and according to a crossover design, patients were random...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2036.1995.tb00369.x
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abstract:BACKGROUND:The duration of Helicobacter pylori eradication regimens has decreased to 1 week with cure rates of over 90%. This can be attributed to the use of triple drug regimens including potent inhibitors of gastric acid secretion and clarithromycin. There is no theoretical reason why shorter regimens should not be p...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.13458
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abstract:BACKGROUND:Recurrent hepatitis C represents a major challenge for the liver transplant community. Given the potentially significant impact that hepatitis C recurrence has on graft and patient survival, several treatment strategies have been utilized to prevent/slow the progression to hepatitis C-related graft failure. ...
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pub_type: 杂志文章,评审
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2018-03-01 00:00:00
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更新日期:2013-01-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1994-10-01 00:00:00
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更新日期:2005-06-01 00:00:00