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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Cohort 2: Cmax
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
YHD1119 (Pregabalin 300mg)
YHD1119 (Pregabalin 300mg)
Intervention: YHD1119 (Drug)
Lyrica (Pregabalin 150mg)
Lyrica (Pregabalin 150mg)
Intervention: Lyrica (Drug)
Outcomes
Primary Outcomes
Cohort 2: Cmax
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 2: AUCtau
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 1: AUCtau
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Cohort 1: Cmax
Time Frame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Secondary Outcomes
No secondary outcomes reported