Trials / Completed

CompletedNCT03261427

Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers

A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 17 (actual)

Sponsor: Yungjin Pharm. Co., Ltd. · Industry
Sex: All
Age: 19 Years – 55 Years
Healthy volunteers: Accepted

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.

Conditions

Healthy

Interventions

Type	Name	Description
DRUG	Lyrica 150Mg Capsule	150 mg oral administered (BID)
DRUG	YNP-1807 330Mg Tablet	330 mg oral administered (QD)

Timeline

Start date: 2017-09-14
Primary completion: 2017-10-11
Completion: 2018-03-29
First posted: 2017-08-25
Last updated: 2019-07-10

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03261427. Inclusion in this directory is not an endorsement.