drugset / Trial / NCT02442752
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) \[after daily administration for 7 days\] and safety \[after daily administration for 8 weeks\] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.
Timeline
- Start
- 2025-06-15
- Primary completion
- 2025-12-23
- Completion
- 2025-12-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexlansoprazole | Other / unclassified | 10 mg | Oral |
| Subject | Dexlansoprazole | Other / unclassified | 15 mg | Oral |
| Subject | Dexlansoprazole | Other / unclassified | 20 mg | Oral |
| Subject | Dexlansoprazole | Other / unclassified | 30 mg | Oral |