drugset / Trial / NCT03261427
Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.
Timeline
- Start
- 2017-09-14
- Primary completion
- 2017-10-11
- Completion
- 2018-03-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pregabalin | Small molecule | 150 mg | Oral |
| Comparator | Pregabalin | Small molecule | 330 mg | Oral |
Indications
No indication recorded.