Aim: To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers.
Methods: A total of 60 patients with active duodenal ulcers were enrolled and randomized to receive esomeprazole enteric-coated capsules (40 mg) or esomeprazole magnesium (40 mg), once daily, for 4 consecutive wk, with ulcer healing being monitored by endoscopy. Safety and tolerability were also assessed.
Results: Fifty seven patients completed the whole trial. The ulcer healing rates at the end of wk 2 were 86.7% and 85.2% in the esomeprazole enteric-coated capsules and esomeprazole magnesium groups, respectively (P = 0.8410), and reached 100% at the end of wk 4 in both groups. Symptom relief at the end of wk 2 was 90.8% in the esomeprazole enteric-coated capsules group and 86.7% in the esomeprazole magnesium group (P = 0.5406); at the end of wk 4 symptom relief was 95.2% and 93.2%, respectively (P = 0.5786). Adverse events occurred in 16.7% of the esomeprazole enteric-coated capsules group and 14.8% of the esomeprazole magnesium group (P = 1.0000).
Conclusion: The efficacies of esomeprazole enteric-coated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of both drugs were comparable.
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http://dx.doi.org/10.3748/wjg.14.1941 | DOI Listing |
Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi
January 2025
The First Clinical Medical College of Xuzhou Medical University,Xuzhou,221000,China.
To explore the efficacy of vonoprazan fumarate in the treatment of laryngopharyngeal reflux disease(LPRD) evaluated by the Chinese version of the RSS-12 scale. A total of 100 LPRD patients treated in the otolaryngology-head and neck surgery outpatient clinic of our hospital were randomly divided into two groups(50 cases each). The observation group was treated with vonoprazan fumarate(20 mg, once daily), and the control group was treated with esomeprazole enteric-coated capsules(20 mg, twice daily) for 12 weeks.
View Article and Find Full Text PDFClin Ther
November 2024
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea. Electronic address:
Purpose: A fixed-dose combination (FDC) of proton pump inhibitors (PPIs) and antacid salts enables rapid acid suppression through the neutralizing effect of the antacid salt and the rapid absorption of PPIs. This study aimed to compare the pharmacokinetics (PKs) and pharmacodynamics (PDs) of a recently formulated FDC of esomeprazole and magnesium hydroxide to the enteric-coated esomeprazole in healthy subjects.
Methods: A randomized, open-label, multiple-dose, two-treatment, two-way crossover design was conducted in healthy subjects.
Clin Pharmacol Drug Dev
July 2023
Office of Drug Clinical Trial Institution, Xianning Central Hospital, First Affiliated Hospital of Hubei University of Science and Technology, Xianning, China.
This bioequivalence study is critically important for drug production. Recently, a local pharmaceutical company produced esomeprazole magnesium enteric-coated capsules, a major drug to help to eradicate Helicobacter pylori, but the bioequivalence is not well known. The present study aimed to evaluate the bioequivalence of the 2 esomeprazole magnesium enteric-coated capsules and their pharmacokinetics and safety in 3 biological equivalence trials: fasting, feeding, and mixing.
View Article and Find Full Text PDFFront Pharmacol
April 2023
Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, Jiangsu, China.
The main purpose of this study was to evaluate the pharmacokinetics, bioequivalence, and safety properties between a new generic and a brand reference formulation of esomeprazole enteric-coated tablets 20 mg in healthy Chinese subjects under fasting and fed conditions. The fasting study was an open-label, randomized, two-period crossover study conducted in 32 healthy Chinese volunteers, and the fed study was a four-period crossover study conducted in 40 healthy Chinese volunteers. Blood samples were collected at the specified time points and determined to obtain the plasma concentrations of esomeprazole.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!