drugset / Trial / NCT04173611
Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers
RandomizedSequentialQuadruple-blindTreatment
Summary
Primary objective: To assess the safety and tolerability of EXPAREL® administered as a single intrathecal injection in healthy volunteers Secondary objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EXPAREL® administered as a single intrathecal injection in healthy volunteers
Timeline
- Start
- 2020-06-08
- Primary completion
- 2020-12-07
- Completion
- 2020-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 13.3 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 15 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 26.6 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 39.9 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 53.2 mg | Intrathecal |
Indications
No indication recorded.