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

July 8, 2019 updated by: Yungjin Pharm. Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- Yonsei-ro Seodaemun-gu
  - Seoul, Yonsei-ro Seodaemun-gu, Korea, Republic of, 120-752
    - Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

19 years to 55 years healthy volunteers adult at screening visit
For male, weight is more than 55 kg, for female, weight is more than 50 kg.
Body mass index(BMI) value : 18.5 to 25.0 kg/m2
If female, should be included one at least as following
- menopausal(menstruation for 2 years minimum)
- surgery infertility

Exclusion Criteria:

Any history of drug overdose or dependence
Female who is pregnant or nursing
AST, ALT > ULN*1.25
Total bilirubin > ULN*1.5
CPK > ULN*1.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YNP-1807 Tablet(Pregabalin 330mg) YNP-1807(Pregabalin 330mg), QD	Drug: YNP-1807 330Mg Tablet 330 mg oral administered (QD)
Active Comparator: Lyrica Capsule(Pregabalin 150mg) Lyrica Capsule(Pregabalin 150mg), BID	Drug: Lyrica 150Mg Capsule 150 mg oral administered (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part I : AUClast of Pregabalin Time Frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part I : Cmax of Pregabalin Time Frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : AUCτ,ss of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : Cmax,ss of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Part I : AUCinf of Pregabalin Time Frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part I : Tmax of Pregabalin Time Frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part I : t1/2 of Pregabalin Time Frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part I : Vd/F of Pregabalin Time Frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part I : CL/F of Pregabalin Time Frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : Cmin,ss of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : AUClast,ss of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : Tmax,ss of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : t1/2 of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : CLss/F of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : Vdss/F of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : accumulation ratio(Cmax) of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : accumulation ratio(AUCτ) of Pregabalin Time Frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yungjin Pharm. Co., Ltd.

Investigators

Principal Investigator: MinSoo Park, MD,PhD, Severance hospital, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2017

Primary Completion (Actual)

October 11, 2017

Study Completion (Actual)

March 29, 2018

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

YJ16-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Healthy

Clinical Trials on YNP-1807 330Mg Tablet

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