PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers

January 14, 2019 updated by: Yuhan Corporation

A Open-label, Randomized, Crossover Clinical Trial to Assess the PK of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR and the Food Effect of High Fat Diet After Single Dosing in Healthy Male Volunteers

This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cohort 1 study is to assess the PK of Pregabalin controlled release formulation as compared to Pregabalin immediate release formulation. Cohort 1 subjects will be admitted to the clinic at Day 1. All subjects will receive multiple dosing for three days of YHD1119 or Pregabalin IR and will remain in the clinic until completion of all assessment on Day 19 including collection of PK sample. The treatment periods were separated by a washout period (10-17 days).

Cohort 2 study is to assess the food effect of high fat diet after single dosing. Cohort 2 subjects will be admitted to the clinic at Day -1. All subjects will receive a single dose of YHD1119 and will remain in the clinic until completion of all assessment on Day 9 including collection of PK sample. The treatment periods were separated by a washout period (7-14 days).

Study Type

Interventional

Enrollment (Actual)

64

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
      • Jeonju, Korea, Republic of, 561-712
        • Chonbuk National University 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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male with body mass index (BMI) between 18.5 and 28 kg/m2
  • Who has not suffered from clinically significant disease
  • Provision of signed written informed consent

Exclusion Criteria:

  • History of and clinically significant disease
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
  • Administration of other investigational products within 3 months prior to the first dosing

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
Active Comparator: Lyrica (Pregabalin 150mg)
Drug: Lyrica
2 by 2
Other Names:
  • Pregabalin 150mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cohort 1: Cmax
Time Frame: Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Cohort 1: AUCtau
Time Frame: Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Cohort 1: Cmax
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 1: AUCtau
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 2: Cmax
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 2: AUCtau
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

Collaborators and Investigators

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

Sponsor

Yuhan Corporation

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

January 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

May 25, 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

  • YHD1119-102

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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