Trial reportBritish journal of clinical pharmacology2019
Efficacy, safety and pharmacokinetics of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control.
Trial report in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Ilaprazole-amoxicillin dual therapy at high dose as a first-line treatment for helicobacter pylori infection in Hainan: a single-center, open-label, noninferiority, randomized controlled trial.BMC gastroenterology · 2023Trial
- Efficacy, safety and pharmacokinetics of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control.British journal of clinical pharmacology · 2019Trial
- An Evaluation of the Inhibitory Effect of Apatinib on Ilaprazole Metabolism: in vitro, in vivo and in silico Study.Drug design, development and therapy · 2026Article
- Efficacy and safety of ilaprazole for stress ulcer - associated upper gastrointestinal bleeding prophylaxis in critically ill patients: a randomized, double-blind, non-inferiority phase 3 trial.Annals of intensive care · 2026Article
- Article
- Impact of Eprazole Sodium combined with somatostatin on treatment efficacy and coagulation function of patients with upper gastrointestinal bleeding: A retrospective study.Pakistan journal of medical sciences · 2025Article
- Simultaneous Determination of Multiple Acid-Suppressing Drugs by UPLC-MS/MS Method and Application for Pharmacokinetics Study.Drug design, development and therapy · 2025Article
- Delineating CYP2C19-mediated Interactions: Network Pharmacology Investigation of Ilaprazole and ClopidogrelCurrent drug discovery technologies · 2025Article
- Computational drug-drug interaction prediction mediated by CYP450 isoforms of Ilaprazole coadministered with clopidogrel.Future science OA · 2024Article
- Newer, Older, and Alternative Agents for the Eradication ofAntibiotics (Basel, Switzerland) · 2023Review
- Population pharmacokinetic modeling of ilaprazole in healthy subjects and patients with duodenal ulcer in China.Frontiers in pharmacology · 2023Article
- Efficacy and safety of high-dose ilaprazole-amoxicillin dual therapy forFrontiers in pharmacology · 2023Article
- A Comparison of Doxycycline and Amoxicillin Containing Quadruple Eradication Therapy for TreatingPathogens (Basel, Switzerland) · 2022Article
- Effects of ilaprazole on the steady-state pharmacodynamics of clopidogrel in healthy volunteers: An open-label randomized crossover study.Frontiers in pharmacology · 2022Article
- Accelerating Development of Benziamidazole-Class Proton Pump Inhibitors: A Mechanism-Based PK/PD Model to Optimize Study Design with Ilaprazole as a Case Drug.Pharmaceutics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe objectives were to investigate the pharmacokinetics, pharmacodynamics and safety of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control, and then recommend the dosage regimen for Phase 2b/3 studies.
methodsThree clinical studies were performed. First, 16 healthy subjects received infusion of ilaprazole 30 mg or esomeprazole 80 mg. Second, 12 healthy subjects received ilaprazole 20 mg followed by 10 mg once daily for 2 days. Finally, 20 patients with duodenal ulcers received ilaprazole 20 mg followed by 10 mg for 2 days or esomeprazole 40 mg twice daily for 3 days. Serial blood samples were collected and intragastric pH was recorded.
resultsThe mean percentages time of intragastric pH >6 was 63.6 and 51.7% for healthy subjects after receiving ilaprazole 30 mg and esomeprazole 80 mg. Linear pharmacokinetics was observed when the dose was increased to 30 mg but the effect was saturated. Ilaprazole 20 mg followed by 10 mg for 2 days provided higher plasma exposure in healthy subjects than patients, but the effect was comparable. After multiple administrations, ilaprazole provided similar effect to esomeprazole. Ilaprazole infusion was safe and well tolerated without serious adverse events.
conclusionsIlaprazole provided comparable effect of pH control to esomeprazole, with lower dose and fewer times of administration. There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibition. A loading dose of ilaprazole 20 mg followed by 10 mg once daily for 2 days was recommended for Phase 2b/3 studies.
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