Overview

This trial has been completed.

Condition peripheral neuropathy pain
Treatments yhd1119, lyrica
Phase phase 1
Sponsor Yuhan Corporation
Start date January 2016
End date April 2016
Trial size 64 participants
Trial identifier NCT02783638, YHD1119-102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
YHD1119 (Pregabalin 300mg)
yhd1119 Pregabalin 300mg
2 by 2
(Active Comparator)
Lyrica (Pregabalin 150mg)
lyrica Pregabalin 150mg
2 by 2

Primary Outcomes

Measure
Cohort 1: Cmax
time frame: 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
time frame: 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: Cmax
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 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

Eligibility Criteria

Male participants from 19 years up to 50 years old.

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

Additional Information

Official title 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
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yuhan Corporation.