drugset / Trial / NCT06233149
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition
RandomizedCrossoverOpen-labelBasic science
Summary
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, full replicate crossover design with four-period, two-treatment, and two-sequence under fed condition and at least 7 days washout period between the doses.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2024-11-19
- Completion
- 2024-12-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esomeprazole | Small molecule | 40 mg | Oral |
Indications
No indication recorded.