A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

January 14, 2019 updated by: Yuhan Corporation

A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers

The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 19~50 years old, healthy male volunteers
  • >55Kg(Body weight) and 18.5<BMI<28

Exclusion Criteria:

  • AST or ALT > 3 * Upper normal range (Lab)
  • Total bilirubin > 2.0 mg/dl
  • Systolic BP >140 OR <90, Diastolic BP >100 OR <60

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YHD1119
Pregabalin 300mg
Drug: YHD1119
2 by 2
Other Names:
  • Pregabalin 300mg
Drug: Lyrica
2 by 2
Other Names:
  • Pregabalin 150mg
Active Comparator: Lyrica
Pregabalin 150mg
Drug: YHD1119
2 by 2
Other Names:
  • Pregabalin 300mg
Drug: Lyrica
2 by 2
Other Names:
  • Pregabalin 150mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax,ss
Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCtau
Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
AUClast,ss
Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCinf,ss
Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Tmax,ss
Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Collaborators and Investigators

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

Sponsor

Yuhan Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHD1119-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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