An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects
Phase of Trial: Phase I
Latest Information Update: 19 Jan 2018
At a glance
- Drugs Esomeprazole (Primary)
- Indications Bleeding ulcer; Duodenal ulcer; Gastric ulcer; Gastro-oesophageal reflux; Helicobacter infections; NSAID-induced ulcer; Reflux oesophagitis; Zollinger-Ellison syndrome
- Focus Pharmacodynamics
- Sponsors AstraZeneca
- 19 Jan 2018 According to an AstraZeneca media release, the approval was based on D961TC00002 and D961TC00004 trials.
- 19 Jan 2018 According to an AstraZeneca media release, the MHLW has approved a partial registration change in terms of additional dosage and administration for children aged 1 year and older for Nexium 10 mg and 20 mg Capsules as a PPI indicated for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis (initial treatment), nonerosive reflux disease, and Zollinger-Ellison syndrome as well as marketing approval for Nexium 10 mg and 20 mg Granules for Suspension, Sachet with the same indication.
- 08 Jan 2014 Status changed from recruiting to completed, ClinicalTrials.gov record.