A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02783183

Enrollment

Registered

2016-05-26

Start date

2016-06-30

Completion date

2016-11-30

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 Nueropathy Pain

Brief 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.

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

* 19\ 50 years old, healthy male volunteers * \>55Kg(Body weight) and 18.5\<BMI\<28

Exclusion criteria

* AST or ALT \> 3 \* Upper normal range (Lab) * Total bilirubin \> 2.0 mg/dl * Systolic BP \>140 OR \<90, Diastolic BP \>100 OR \<60

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026