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

Yuhan

Status and phase

Completed

Phase 1

Conditions

Peripheral Neuropathy Pain

Treatments

Drug: YHD1119

Drug: Lyrica

Study type

Interventional

Funder types

Industry

Identifiers

NCT02783638

YHD1119-102

Details and patient eligibility

About

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.

Full 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).

Enrollment

64 patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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