drugset / Trial / NCT05517486
Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects. The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects. Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.
Timeline
- Start
- 2022-07-26
- Primary completion
- 2022-08-21
- Completion
- 2023-05-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 50 mg | Subcutaneous |
| Subject | Bupivacaine | Other / unclassified | 100 mg | Subcutaneous |
| Subject | Bupivacaine | Other / unclassified | 200 mg | Subcutaneous |