drugset / Trial / NCT03706924
Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects
RandomizedParallel-groupOpen-labelBasic science
Summary
Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. The study will also assess safety profile of study drugs.
Timeline
- Start
- 2018-06-01
- Primary completion
- 2018-10-12
- Completion
- 2018-10-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Elsulfavirine | Small molecule | — | — |
| Comparator | Tenofovir | Small molecule | — | — |
| Subject | VM-1500FDC | Unknown | — | — |