Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01420913

Enrollment

Registered

2011-08-22

Start date

2011-08-31

Completion date

2011-08-31

Last updated

2011-08-22

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

Conditions

Healthy

Keywords

To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C

Brief summary

The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule. YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation. Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2

Interventions

DRUGPregabalin

Pregabalin 300mg a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 20\ 45 years old, healthy adult male subject * \>55 Kg(Body weight) and \< ideal body weight ± 20%

Exclusion criteria

* AST or ALT \> 1.25 \* Upper normal range (Lab) * Total bilirubin \> 1.5 \* Upper normal range * Systolic BP \>140 OR \<100, Diastolic BP \>90 OR \<65

Design outcomes

Primary

Measure	Time frame	Description
Cmax,ss	36 hr	—
AUCtau	36 hr	—
Safety monitoring	14 days	Laboratory findings Adverse event

Secondary

Measure	Time frame
AUClast AUCinfinity Tmax,ss t1/2	36 hour
t 1/2	36 hr
AUCinfinity	36 hr
Tmax,ss	36 hr

Countries

South Korea

Outcome results

None listed

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