drugset / Trial / NCT04471922
A Multiple Ascending High Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (7 days) ascending dose (60mg QD, 80mg QD, 100mg Qd) administrationof Anaprazole in healthy Chinese subjects. 45 subjects, 15 subjects for each dose group. In each dose group, 10 subjects take investigational drug (anaprazole), 2 subjects take active comparatory drug (rabeprazole), 3 subjects take placebo.
Timeline
- Start
- 2019-03-21
- Primary completion
- 2019-03-28
- Completion
- 2019-03-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anaprazole | Other / unclassified | 60 mg | Oral |
| Subject | Anaprazole | Other / unclassified | 80 mg | Oral |
| Subject | Anaprazole | Other / unclassified | 100 mg | Oral |
| Comparator | Rabeprazole | Small molecule | 20 mg | Oral |
Indications
No indication recorded.