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

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: Peripheral Neuropathy Pain
• Intervention / Treatment: Drug: YHD1119; Drug: Lyrica

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

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of, 561-712
    • Chonbuk National University Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 1: AUCtau	YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 2: Cmax	YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 2: AUCtau	YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

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: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: YHD1119-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No