NCT02783638

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Peripheral Neuropathy Pain

Interventions

Type	Name	Description
DRUG	YHD1119	2 by 2
DRUG	Lyrica	2 by 2

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-04-01
• Completion: 2016-09-01
• First posted: 2016-05-26
• Last updated: 2019-01-16

Locations

1 site across 1 country: South Korea