Overview

This trial has been completed.

Condition peripheral nueropathy pain
Treatments yhd1119, lyrica
Phase phase 1
Sponsor Yuhan Corporation
Start date June 2016
End date August 2016
Trial size 32 participants
Trial identifier NCT02783183, YHD1119-103

Summary

The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

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

Primary Outcomes

Measure
Cmax,ss
time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCtau
time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Secondary Outcomes

Measure
AUClast,ss
time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCinf,ss
time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Tmax,ss
time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Eligibility Criteria

Male participants from 19 years up to 50 years old.

Inclusion Criteria: - 19~50 years old, healthy male volunteers - >55Kg(Body weight) and 18.5 3 * Upper normal range (Lab) - Total bilirubin > 2.0 mg/dl - Systolic BP >140 OR <90, Diastolic BP >100 OR <60

Additional Information

Official title A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yuhan Corporation.