drugset / Trial / NCT03591146
Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management
RandomizedSequentialQuadruple-blindSupportive care
Summary
Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®
Timeline
- Start
- 2018-07-31
- Primary completion
- 2019-01-05
- Completion
- 2019-01-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ropivacaine | Other / unclassified | 150 mg | Other |
| Subject | TLC590 | Unknown | 190 mg | Other |
| Subject | TLC590 | Unknown | 380 mg | Other |
| Subject | TLC590 | Unknown | 475 mg | Other |
| Subject | TLC590 | Unknown | 570 mg | Other |
Indications
No indication recorded.