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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02783638

Enrollment

Registered

2016-05-26

Start date

2016-01-31

Completion date

2016-09-30

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy Pain

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).

Interventions

DRUGYHD1119

2 by 2

DRUGLyrica

2 by 2

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026