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

NCT03261427 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-07-10

No results posted yet for this study

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

DRUG

Lyrica 150Mg Capsule

150 mg oral administered (BID)

DRUG

YNP-1807 330Mg Tablet

330 mg oral administered (QD)

Sponsors & Collaborators

  • Yungjin Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • MinSoo Park, MD,PhD · Severance Hospital, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2017-10-11
Completion
2018-03-29

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261427 on ClinicalTrials.gov