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

Phase 1

Completed

• Conditions: Peripheral Neuropathy Pain
• Interventions: Drug: Lyrica; Drug: YHD1119

• Registration Number: NCT02783638
• Lead Sponsor: Yuhan Corporation

Brief Summary

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.

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-15
• Primary Completion: 2016-04
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lyrica (Pregabalin 150mg)	Lyrica	Lyrica (Pregabalin 150mg)
YHD1119 (Pregabalin 300mg)	YHD1119	YHD1119 (Pregabalin 300mg)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of