A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases
Phase of Trial: Phase I
Latest Information Update: 02 Apr 2018
At a glance
- Drugs Dexlansoprazole (Primary)
- Indications Gastro-oesophageal reflux
- Focus Pharmacokinetics
- Sponsors Takeda
- 14 Sep 2017 Planned End Date changed from 1 Jul 2017 to 23 Dec 2020.
- 14 Sep 2017 Planned primary completion date changed from 1 Jul 2017 to 23 Dec 2020.
- 07 Mar 2016 Status changed from recruiting to suspended as reported by ClinicalTrials.gov record.